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Introduction: Coronavirus 2019 (COVID-19) vaccination rates in pregnant women remain low owing to safety concerns. When evaluating vaccine safety, comparisons with unvaccinated individuals may lead to healthy vaccinee bias. This study aimed to investigate the association between mRNA-based COVID-19 vaccination and pregnancy-related adverse outcomes compared with influenza vaccination., Methods: A propensity score-matched cohort study was conducted using the National Health Insurance Service insurance claims database, combined with COVID-19 and influenza vaccination registration data from the Korea Disease Control and Prevention Agency. Based on the age, comorbidities, insurance type, region, hospital type, gestational age at vaccination, and primiparity, the COVID-19 vaccination-only group and influenza vaccination-only group were matched in a 1:3 ratio, while both (COVID-19 and influenza) vaccination group and influenza vaccination-only group were also matched in a 1:3 ratio. Logistic regression analysis was used to calculate odds ratios (ORs) with 95 % confidence intervals (CIs) between the two groups., Results: From October 18, 2021, to March 3, 2022, 71,902 pregnant women were identified, and the vaccination records of 67,522 individuals were verified. Among them, 610 received the COVID-19 vaccination only, 49,952 received the influenza vaccination only, and 2405 received both vaccines. In the COVID-19 vaccination-only group, the risk of large for gestational age was higher than in the influenza vaccination-only group (OR = 2.285, 95 % CI = 1.155-4.522, P = 0.018). In the group that received both vaccinations, the risk of premature birth was higher (OR = 1.365, 95 % CI = 1.124-1.656, P = 0.002) than that in the influenza vaccination-only group but lower than the domestic baseline incidence rates. No significant differences were observed in other maternal and neonatal outcomes., Conclusion: mRNA-based COVID-19 vaccination in pregnant women is safe without a remarkable increase in adverse maternal and neonatal outcomes. Given the high morbidity and mortality rates of COVID-19 in pregnant women, it is reasonable to recommend COVID-19 vaccination for pregnant women., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hee Jin Cheong reports financial support was provided by Korea Disease Control and Prevention Agency. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Porcine circovirus type 2 (PCV2) is a highly damaging pathogen for pig farming, causing significant economic losses. Despite the availability of vaccines based on different technologies, the virus steadily infects the world's pig population. In this context, virus-like particles (VLPs) constitute appealing alternatives for vaccine development as they lack the viral genome but present intact external surfaces. Using PCV2 VLPs expressed and purified from Expi293F cells, we demonstrate the potential to generate high-purity VLPs with excellent antigenic properties through biochemical, biophysical, and immunological characterization. Using different techniques, we also determined the melting temperature of these VLPs at nearly 55 °C. Furthermore, we conducted multiscale simulations of whole VLPs combined with multiple sequence analyses to provide a new perspective into the stability determinants. Computational results support our findings and underscore the importance of protein-nucleic acid interactions in stabilizing the VLP structure. Moreover, we spotted an unforeseen correlation between amino acid conservation, solvent exposure, and flexibility, revealing a link to viral assembly and immune evasion. These novel insights are crucial to guide the development of stabilized VLP for new vaccine prototypes to respond to the emergence of new PCV2 genotypes., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Purpose: Explore mothers of adolescents' use of social media and the influence of social media on hesitancy regarding HPV vaccine., Methods: A national online survey of mothers of adolescents aged 9-17 years was conducted in August 2023, with participants recruited from an online research panel of US residents. The study examined socio-demographic factors, social media use patterns, and influence of social media and their association with HPV vaccine hesitancy., Results: Survey sample included 3968 mothers of adolescents. Specifically among the social media variables, multivariable analysis revealed that Facebook influence was negatively associated with HPV vaccine hesitancy (β = -0.016, 95 % confidence interval [CI] = (-0.029, -0.003), p = 0.019), while uncertainty about social media messages (veracity) (β = 0.067, 95 % CI = (0.021, 0.113), p = 0.004) were associated with increased vaccine hesitancy. No significant associations were found with the number of daily-used social media platforms or influence from other platforms., Discussion: Our findings highlight the impact of uncertainty about social media messages and its effect on parents' HPV vaccine hesitancy. Our findings also highlight the potential role of health care providers in reducing vaccine hesitancy during clinical encounters. Future research is needed to better understand the elements (content, approach, platforms) of effective social media communication interventions to decrease vaccine hesitancy and improve HPV vaccination rates among adolescents in the US., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: This study aimed to evaluate parents' main reasons for lack of intent to vaccinate their adolescent against human papillomavirus (HPV) from 2019 to 2021 and to examine changes in these main reasons stratified by sex of the adolescent., Methods: NIS-Teen data from 2019 to 2021 were used. Parents who had not vaccinated their adolescent aged 13-17 against HPV and had no intent to do so in the next 12 months were asked the main reason behind this decision. Reasons were grouped into eight domains. A multinomial logistic regression model stratified by sex was used to assess changes in the likelihood of each domain for 2020 and 2021 in comparison to 2019., Results: A significant interaction between the reasons for lack of intent to vaccinate against HPV and year by sex was documented (p < 0.001). For males, the odds of parents reporting vaccine misinformation (ORadj: 1.30, 95 % CI: 1.26, 1.35), safety and effectiveness concerns (ORadj: 1.08, 95 % CI: 1.05, 1.12), systemic barriers (ORadj: 2.57, 95 % CI: 2.48, 2.66), lack of knowledge (ORadj: 1.44, 95 % CI: 1.39, 1.49), sociocultural barriers (ORadj: 3.20, 95 % CI: 3.09, 3.32), already UTD (ORadj: 2.48, 95 % CI: 2.39, 2.56), and handicapped/special needs/illness (ORadj: 1.88, 95 % CI: 1.79, 1.97), were significantly higher in 2021 compared to 2019. Whereas for females, the odds of reporting all domains were significantly lower in 2021 compared to 2019., Conclusion: The main domain reported was vaccine misinformation. Parents of males were more likely to report all domains in 2021 compared to 2019, the inverse of females. These can be addressed through public health interventions such as launching media campaigns to combat vaccine misinformation tailored to parents of male adolescents., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: The COVID-19 pandemic has shown the immediate risk for global and public health posed by vaccination inequities worldwide. The regions most affected are low- and middle-income countries (LMICs). In addition to systemic challenges, vaccine hesitancy driven by low vaccine confidence has been identified as a threat to vaccine uptake. The aim of this systematic review of qualitative literature is to explore the determinants of COVID-19 and non-COVID-19 vaccine confidence in LMICs., Methods: A systematic review was conducted following the PRISMA and ENTREQ guidelines. The electronic databases Cinahl, Embase, Pubmed, Scopus and Web of Science were searched for qualitative studies focusing on the topic of interest in LMICs published between 2013 and 2023. The quality of the studies was assessed using the Joanna Briggs Institute's Checklist for Qualitative Research. A thematic synthesis was conducted. The study was registered on the Open Science Framework platform., Findings: 66 studies were included in the review. Three main determinants of vaccine confidence were identified: (1) General perceptions of the safety and efficacy of vaccines; (2) Information and experience; (3) Trust in healthcare providers, institutions, and systems. General perceptions of vaccine safety and efficacy were similar between COVID-19 and non-COVID-19 vaccines, and doubts regarding vaccine safety were neither new nor exclusive to the COVID-19 vaccine, indicating a persisting challenge. Furthermore, low vaccine confidence was partly determined by broader dynamics of mistrust towards Western countries and institutions, which was reflected for both vaccine groups. While conspiracy theories have been persisting determinants of low confidence, low COVID-19 vaccine confidence was partly determined by what was perceived as a lack of specific information., Conclusion: Persistent challenges to vaccine confidence were identified, rooted in colonial legacies and global health inequities, as well as limited intercultural approaches to building trust with regards to vaccines., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Baltica Cabieses reports financial support was provided by Health Equity Catalyst Fund, MERCK. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: To evaluate human papillomavirus (HPV) vaccination coverage among adolescents in the U.S. using birth cohort analysis., Methods: We conducted a birth cohort analysis among adolescents born during 1999-2009 using National Immunization Survey-Teen (NIS-Teen), a random-digit dialed household telephone survey that also includes vaccination data from providers. We analyzed 131,553 records from 2016 to 2022 NIS-Teen data to determine: trends in coverage with ≥1 HPV vaccine dose before age 13 years and cumulative coverage from age 13-17 years; sociodemographic factors associated with HPV vaccination before age 13 years; missed HPV vaccination opportunities and the potential achievable coverage if opportunities were not missed; and trends in completion of HPV vaccination series. Regression analysis and Kaplan-Meier method provided the average percentage increase in coverage, and cumulative coverage from age 13-17 years stratified by birth cohorts, respectively., Results: HPV vaccination initiation before age 13 years increased from 27.0 % among adolescents born in 1999 to 69.8 % among those born in 2009. Overall, cumulative percent with ≥1 HPV vaccine dose increased from 51.3 % before age 13 years to 74.9 % through age 17 years. Having a preventive visit at ages 11-12 years and being insured were associated with higher ≥1 HPV vaccine dose coverage. Among the 38,568 (29.3 %) adolescents unvaccinated for HPV, 31,513 (82.5 %) missed ≥1 HPV vaccination opportunity. The potential achievable coverage if opportunities were not missed was 94.8 %. Completion of HPV vaccination series before age 13 years increased from 10.3 % among adolescents born in 1999 to 42.2 % among those born in 2009., Conclusions: Coverage with ≥1 HPV vaccine dose increased by birth cohort among adolescents born 1999-2009 but remained suboptimal, especially among uninsured adolescents. Missed opportunities may be reduced by effective HPV vaccination implementation and uptake strategies and by administering all recommended vaccines during the same visit., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Diseases caused by Streptococcus pneumoniae (pneumococcus) produce a great impact on public health, killing about one million people annually despite available vaccines. Recent research has revealed that the pneumococcus produces extracellular vesicles (pEVs), which display selective cargo and hold potential for vaccine development. Here, we evaluated the immunogenicity and protective potential of pEVs derived from a non-encapsulated pneumococcal strain (R6) using murine models of pneumococcal colonization and invasive pneumonia. Characterization of the immune response revealed that while pEVs contain multiple virulence determinants, immunization with these nanoparticles only induces antibodies against a subset of them. Specifically, subcutaneous immunization elicits a high antibody response against PspA, a modest response against PrsA, and limited response against Ply, MalX and PsaA. The antibody response was further supported by agglutination studies, showing that sera from pEV immunized mice agglutinate pneumococci and that PspA contributes to this response in a strain-dependent manner. Subcutaneous immunization with pEVs provides protection in the invasive pneumonia model whereas nasal immunization results in one log reduction in pneumococcal colonization of the upper respiratory tract. Finally, PspA is a strong contributor to protection in the invasive model and provides a degree of protection even across heterologous families of PspA. We conclude that pEVs demonstrate potential for vaccine development, protecting across capsular types and providing some degree of protection across heterologous PspA variants., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Vaccine hesitancy fueled by ignorance, negativity, and false information on social media affects public health globally. Brazil's decline in vaccination, influenced by denialism and misinformation, increases the risk of polio reintroduction in Latin America. Combatting scientific Fake News is crucial to prevent irreversible consequences to public health., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Hepatitis E virus genotype 3 (HEV-3) is a zoonotic pathogen capable of infecting human, porcine, and other animal hosts. Despite a broad host range and abundance of species that act as reservoirs for human infections, no commercially available animal vaccines against HEV-3 are currently available. In the present study, we tested the capacity of recombinant aa 112-608 wild boar-derived HEV-3 capsid protein (rORF2p) to induce an immune response in immunized pigs. Four 6 week old pigs were administered 1 ml of 200 μg/ml rORF2p, followed by booster administration after 14 days. Blood samples were collected until 28 days after initial immunization. Dominant cell phenotypes and anti-HEV IgG concentrations were determined. A significant anti-HEV IgG, monocyte/macrophage, B cell and T cell response has been detected in immunized pigs. In turn, our findings suggest the capacity of rORF2p to elicit an immune response in pigs, suggesting the potential for its use as a vaccine candidate., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors attest they meet the ICMJE criteria for authorship., (Copyright © 2024. Published by Elsevier Ltd.)

Introduction: Our study aimed to assess parents' perceptions of respiratory syncytial virus (RSV) and their attitudes towards the RSV vaccine in China., Method: The cross-section study was performed between August 21 and November 15, 2023, in Jiangsu province, eastern China. We collected socio-demographics, awareness, knowledge, perceptions of susceptibility and severity of RSV, and attitudes towards RSV vaccine using online survey questionnaire from parents of child aged ≤14 years old. The chi-square test and logistic regression model to explore the associated factors., Results: A total of 2135 participants were included. About 26.0 % indicated that they had never heard of RSV (556/2135) and were unaware that infants and young children are at a high risk of contracting RSV (557/2135). The proportion of parents with a child under 1 year of age who were unaware of RSV was notably higher than that of parents with children in other age groups. 42.9 % of parents (916/2135) showed low level of perceived susceptibility of contacting RSV infection for their child. 70.6 % of parents (1508/2135) expressed their willingness to vaccinate their child against RSV. The most common reason for refusing the RSV vaccine was "Concern about vaccine's safety or side effects." 60.8 % of participants (1299/2135) considered a price of the RSV vaccine below 200 CNY (28 USD) as acceptable., Conclusion: The parents, particularly those with younger children, exhibited limited awareness and knowledge regarding RSV infection. Our study also showed the potential role of vaccine price as a barrier to the future use of RSV vaccine in China., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The author is an Editorial Board Member/Editor-in-Chief/Associate Editor/Guest Editor for Vaccine and was not involved in the editorial review or the decision to publish this article.

Background: Increasing childhood vaccination, family planning, healthcare access, and women's empowerment are targets of the Sustainable Development Goals (SDG). Barriers to healthcare access impede vaccination; tackling goals holistically could create larger gains than siloed efforts. We studied Nepal, Senegal, and Zambia to test the association between childhood vaccinations and other SDG indicators to identify clustered deprivations. We quantified how under-immunized children with few - or no - vaccines and their mothers were vulnerable in SDG areas., Methods: We analyzed Demographic and Health Surveys from Nepal, Senegal, and Zambia. Through ordinal logistic regressions, controlling for household/mother's characteristics, we identified strong predictors of the number of vaccine doses one-year-old children received. Through bootstrapping and optimal propensity scores matching, we compared children with no or few vaccine doses (0-2 doses in early 2000s, or 0-4 in late 2010s) to children who received eight doses (DTP1-3, MVC1, Pol1-3, and BCG vaccines)., Findings: Mothers of children who received eight doses were 14-30 % more likely than mothers of children with few or no doses to have accessed a health facility in the last year (95 % CIs were 16-44 % in Nepal 2001, -5 % to 33 % Nepal 2016, 3-26 % Senegal 2005, 1-31 % Senegal 2019, 9-38 % Zambia 2001-02, 7-36 % Zambia 2018), knew on average 0.7-1.5 more contraceptive methods (0.9-2.0 Nepal 2005, 0.1-1.5 Nepal 2016, 0.6-1.7 Senegal 2005, 0.2-1.7 Senegal 2019, 0.1-1.4 Zambia 2001-02, 0.5-1.4 Zambia 2018), and had 10-22 % higher literacy rates (12-32 % Nepal 2001, -7 % to 36 % Nepal 2016, 10-26 % Senegal 2005, -3 to 22 % Senegal 2019, -4 % to 28 % Zambia 2001-02, 5-36 % Zambia 2018)., Interpretation: Children with few or no vaccine doses and their mothers were behind in access to family planning, healthcare, and education compared to fully vaccinated children and their mothers. Such differences can further impede immunizations; integrated education and health services are needed to improve vaccination outcomes., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Matthew Freeman, Pinar Keskinocak, Dima Nazzal reports financial support was provided by Bill & Melinda Gates Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: The childhood immunization coverage in Serbian communities in Kosovo after the 1999 armed conflict has not been investigated. The study purpose was to evaluate the trend of immunization coverage with vaccines from the national childhood immunization program in Serbian communities in Kosovo and Metohija from 2003 to 2022., Methods: Data were retrieved from the annual reports of the Public Health Institute of Kosovska Mitrovica received through notifications from the primary health centers where vaccines are being administered. Data were analyzed using the linear regression and join-point regression models., Results: In the examined period, a significant decrease in vaccination coverage was observed for the following diseases: diphtheria, tetanus and pertussis (DTP), polio, as well as measles, mumps and rubella vaccines (MMR), then, the first revaccination for DTP and polio, the second revaccination against diphtheria and tetanus for children (DT) and polio, and the third revaccination against diphtheria and tetanus for adults (dT), as well as the second dose of the MMR vaccine. During the COVID-19 pandemic, a significant decrease in coverage was observed for primary vaccination against: DTP, polio and hepatitis B, first and second doses of the MMR vaccine, as well as the first and second revaccination for DTP and polio, and the third revaccination for dT., Conclusion: A decline in coverage with DTP, MMR, polio and hepatitis B vaccines was observed between 2003 and 2022. This was even more pronounced during the COVID-19 pandemic. Further research on individual-level factors contributing to lower vaccination coverage is warranted., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

In vitro systems based on human peripheral blood mononuclear cells (PBMCs) can bridge the gap between preclinical and clinical vaccine evaluation but have so far mainly been exploited to assess vaccine effects on antigen-presenting cells and T cells. Our study aimed to assess whether B cells present in PBMCs also respond to vaccines and reflect the effects of different vaccine formulations and adjuvants. We stimulated PBMCs with whole inactivated virus (WIV) or split virus (SIV) H5N1 influenza vaccine, with or without the addition of the adjuvant cytosine phosphoguanine (CpG) ODN 2395, and collected the cells and supernatants at different timepoints. B cell subsets were measured by flow cytometry, immunoglobulin (IgG) levels by ELISA, B cell-related genes by qPCR, and cytokine levels by intracellular staining. B cells differentiated more readily to plasmablasts and plasma cells and produced more IgG when PBMC cultures were stimulated with WIV than when stimulated with SIV. In line, PRDM1, XBP1, and AICDA, genes associated with the differentiation of B cells to antibody-secreting cells, were expressed at higher levels in WIV- than in SIV-stimulated PBMCs. The combination of WIV and CpG consistently induced the highest levels of antibody-secreting cell differentiation, IgG production, and B-cells secreting IL-6 and IL-10. Taken together, B cells in human PBMC cultures show distinct responses to different types of vaccines and vaccine/CpG combinations. This underlines the suitability of unfractionated PBMCs for evaluating vaccine effects on different types of human immune cells before running costly clinical trials., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: In June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either 20-valent pneumococcal conjugate vaccine (PCV20) alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all PCV-unvaccinated adults aged ≥65 years (age-based) and for adults aged 19-64 years with conditions that increase the risk for pneumococcal disease (risk-based). This recommendation replaced a previous recommendation for PPSV23 with or without 13-valent pneumococcal conjugate vaccine (PCV13) for these groups., Objective: We conducted a cost-effectiveness analysis of age-based and risk-based use of either PCV15 in series with PPSV23 or PCV20 alone when compared to previous recommendations., Methods: We utilized probabilistic cohort models of all 65-year-olds (age-based) and 19-year-olds (risk-based through age 64 years and age-based at age 65 years). A spreadsheet-based Monte Carlo simulation software was used to estimate immunization costs, medical costs, non-medical costs, and overall disease burden under different vaccine strategies. The model tracked inpatient invasive pneumococcal disease (IPD) and non-bacteremic pneumonia (NBP) in inpatient and outpatient settings. One-way sensitivity analyses incorporated indirect effects of prospective pediatric vaccination with PCV15 and PCV20 on adult IPD and NBP incidence. Costs were reported in 2021 US dollars. All future costs and outcomes were discounted at 3 % per year., Results: Age-based use of either PCV20 alone or PCV15 in series with PPSV23 at age 65 years were both shown to be cost-saving (improved health outcomes and saved costs). Combined cost-effectiveness of risk-based (19-64 years) plus age-based (65 years) (risk-and-age-based) use of PCV20 alone was cost-saving, whereas use of PCV15 in series with PPSV23 increased quality-adjusted life years (QALYs) but cost $412,111 (95 % CI: 270,295, 694,869) per QALY gained., Conclusion: In U.S. adults, replacing the previous recommendations with PCV20 alone or PCV15 in series with PPSV23 improved health outcomes. Except for risk-and-age-based use of PCV15 in series with PPSV23 that resulted in increased cost per QALY gained, the interventions also reduced costs., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Rotavirus is a leading cause of severe diarrheal disease in infants and young children worldwide. Vaccination offers the best protection against this disease, and two rotavirus vaccines were developed in India and included in its routine immunization program. The Government of India's decision to adopt this intervention was supported by a solid base of evidence from clinical trials, as well as substantial research regarding rotavirus disease burden and the potential health and economic value of immunization. Following program implementation, multiple studies were initiated, including three evaluations of effectiveness and several investigations regarding intussusception. These additional data regarding vaccine impact, safety, and delivery from post-introduction evaluations in conditions of real-world use will further strengthen and sustain the immunization program. This manuscript evaluates the status of existing and forthcoming evidence regarding rotavirus vaccination in India through a literature review and consultation with relevant stakeholders. Studies evaluating vaccine impact, effectiveness, safety, health economics, and acceptability, as well as operational and programmatic research, were included in the review. Overall, we found that the evidence base did not contain any major gaps. Nevertheless, additional smaller-scale research studies would be valuable in providing a more complete picture of rotavirus vaccine performance and benefit. Documentation of India's experience with rotavirus vaccines may provide lessons learned for other countries in the Asia region, where rotavirus disease burden remains high, yet vaccine adoption has been slow, as well as for countries worldwide that may be considering implementation of the Indian-made rotavirus vaccines., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Niranjan Bhat reports financial support was provided by Bill & Melinda Gates Foundation. Elisabeth Vodicka reports financial support was provided by Bill & Melinda Gates Foundation. Allison Clifford reports financial support was provided by Bill & Melinda Gates Foundation. Kanduri Balaji Ananth reports financial support was provided by Bill & Melinda Gates Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare that they have no conflict of interest.

Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and lower-middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A public sector manufacturer in Vietnam assessed the immunogenicity of NDV-HXP-S (COVIVAC) relative to an authorized vaccine. This phase 2 stage of a randomised, observer-blind, controlled, phase 1/2 trial was conducted at three community health centers in Thai Binh Province, Vietnam. Healthy males and non-pregnant females, 18 years of age and older, were eligible. Participants were randomised by age (18-59, ≥60 years) to receive one of three treatments by intramuscular injection twice, 28 days apart: COVIVAC at 3 μg or 6 μg, or AstraZeneca COVID-19 vaccine VAXZEVRIA™. Participants and personnel assessing outcomes were masked to treatment. The vaccine dose was selected based on Phase 1 results. A 6 μg dose was chosen to explore the immunogenicity gain over the 3-μg dose. The study's aim is to evaluate the safety and immunogenicity of COVIVAC at two dose levels compared to VAXZEVRIA, the most commonly used COVID-19 vaccine in Vietnam. The main outcome was the induction of 50% neutralising antibody titers against vaccine-homologous pseudotyped virus 14 days (day 43) and 6 months (day 197) after the second vaccination by age group. The primary immunogenicity and safety analyses included all participants who received one dose of the vaccine. ClinicalTrials.govNCT05940194. During August 10-23, 2021, 737 individuals were screened, and 374 were randomised (124-125 per group); all subjects received vaccine dose one and all but three received doses two four weeks later. Subjects 18-59 years of age achieved the following geometric mean titers of PNA 14 days after vaccine dose two: 153⋅28 (95 % CI 124·2-189⋅15) for COVIVAC 3 μg, 176⋅2 (95 % CI 141⋅45-220.27) for COVIVAC 6 μg, and 99⋅92(95 % CI 80.80-123⋅56) for VAXZEVRIA. Subjects ≥60 years of age also achieved potent geometric mean titers of PNA at the same timepoint: 183⋅57 (95 % CI 133.4-252⋅61) for COVIVAC 3 μg, 257⋅87 (95 % CI 181⋅6-367⋅18) for COVIVAC 6 μg, and 79⋅49(95 % CI 55⋅68-113⋅4) for VAXZEVRIA. On day 43, the geometric mean fold rise of 50 % neutralising antibody titers for subjects age 18-59 years was 31·20 (COVIVAC 3 μg N = 82, 95 % CI 25·14-38·74), 35·80 (COVIVAC 6 μg; N = 83, 95 % CI 29·03-44·15), 18·85 (VAXZEVRIA; N = 82, 95 % CI 15·10-23·54), and for subjects age ≥ 60 years was 37·27 (COVIVAC 3 μg; N = 42, 95 % CI 27·43-50·63), 50·10 (COVIVAC 6 μg; N = 40, 95 % CI 35·46-70·76), 16·11 (VAXZEVRIA; N = 40, 95 % CI 11·73-22·13). Among subjects seronegative for anti-S IgG at baseline, the day 43 geometric mean titer ratio of neutralising antibody (COVIVC 6 μg/VAXZEVRIA) was 1·77 (95 % CI 1·30-2·40) for subjects age 18-59 years and 3·24 (95 % CI 1·98-5·32) for subjects age ≥ 60 years. On day 197, the age-specific ratios were 1·11 (95 % CI 0·51-2·43) and 2·32 (0·69-7·85). Vaccines were well tolerated; reactogenicity was predominantly mild and transient. The percentage of subjects with unsolicited adverse events (AEs) during 28 days after vaccinations was similar among treatments (COVIVAC 3 μg 29·0 %, COVIVAC 6 μg 23·2 %, VAXZEVRIA 31·2 %); no vaccine-related AE was reported. Considering that induction of neutralising antibodies against SARS-CoV-2 has been correlated with the efficacy of COVID-19 vaccines, including VAXZEVRIA, our results suggest that vaccination with COVIVAC may afford clinical benefit matching or exceeding that of the VAXZEVRIA vaccine. ClinicalTrials.govNCT05940194., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alessandro Sette reports financial support was provided by National Institutes of Health. Daniela Weiskopf reports a relationship with Moderna Inc. that includes: consulting or advisory. Daniela Weiskopf is an associate editor for Vaccine. La Jolla Institute has patents issued for various aspects of T cell epitope and vaccine design work. Juan Manuel Carreno reports funding was provided by Icahn School of Medicine at Mount Sinai Department of Microbiology. Florian Krammer reports a relationship with Avimex Laboratories that includes: royalties or licenses and consulting. Florian Krammer reports a relationship with Kantaro Biosciences that includes: royalties or licenses. Florian Krammer reports a past relationship with Pfizer that includes: consulting or advisory. Florian Krammer reports a past relationship with Seqirus Inc. that includes: consulting or advisory. Florian Krammer reports a past relationship with GSK that includes: consulting or advisory. Florian Krammer reports a relationship with Gritstone bio Inc. that includes: consulting or advisory. Florian Krammer reports a relationship with CastleVax that includes: equity or stocks, royalties or licenses, and consulting. Florian Krammer has patents regarding SARS-CoV-2 vaccines and serological assays issued to Icahn School of Medicine at Mount Sinai. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The TLR4 (Toll-like receptor 4)-activating agonist MPLA (monophosphoryl lipid A) is a key component of the adjuvant systems AS01 and AS04, utilized in marketed preventive vaccines for several infectious pathogens. As MPLA is a biologically-derived product containing a mixture of several lipid A congeners with a 4' phosphoryl group and varying numbers of acyl chains with distinct activities, extensive efforts to refine its production and immunogenicity are ongoing; notably, the development of the BECC (Bacterial Enzymatic Combinatorial Chemistry) system in which bacteria express lipid A-modifying enzymes to produce a panoply of lipid A congeners. In an effort to characterize the adjuvant activity of these lipid A congeners, we compared biologically-derived and synthetic versions of BECC470 and BECC438 for adjuvant activity in BALB/c mice vaccinated with the HPV (Human papilloma virus) VLP-based vaccine, RG1-VLP. Synthetic BECC compounds compared favorably to biological versions and, in the case of synthetic BECC470, were routinely superior to their biologically-derived BECC counterpart. Synthetic BECC470-adjuvanted vaccines achieved broad spectrum immune activity characterized by elevated levels of total IgG and IgG2a subtype specific to HPV16 L1 VLPs and the HPV16 L2 peptide, as well as robust HPV16-neutralizing antibody titers. In addition, synthetic BECC470 promoted strong T cell responses to HPV16 L1, increased memory B cell frequency, and increased the T follicular helper cell (Tfh) population in draining lymph nodes. In contrast, the biologically-derived form of BECC470 induced an immune profile specific for highest levels of HPV16 L2-specific IgG2a as well as antibodies cross-neutralizing to HPV18 and HPV39. These data confirm that a synthetically-derived BECC compound can be combined with Alhydrogel to adjuvant the RG1-VLP vaccine as can biologically-derived BECC compounds and MPLA, albeit with subtly distinct immune responses. The distinctions in immune profiles triggered by these BECC compounds warrant further exploration for their capacity to activate TLR4 and modulate immune responses to vaccines., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Richard Roden, Reinhard Kirnbauer reports a relationship with Pathovax LLC that includes: board membership and equity or stocks. Robert Ernst reports a relationship with TollereBio Corporation that includes: board membership and equity or stocks. Richard Roden, Reinhard Kirnbauer has patent #US14/875,374 licensed to Johns Hopkins University. Robert Ernst has patent #10358667 and 11124815 pending to TollerBio Corporation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Epidemiological studies suggest that heterogeneity in influenza vaccine antibody response can be associated with specific host factors, including pre-vaccination immune status, age, gender, and vaccination history. However, the pattern of reported associations varies between studies. To better understand the underlying influences on antibody responses, we combined host factors and vaccine-induced in-host antibody kinetics from a cohort study conducted across multiple seasons with a unified analysis framework. We developed a flexible individual-level Bayesian model to estimate associations and interactions between host factors, including pre-vaccine HAI titre, age, sex, vaccination history and study setting, and vaccine-induced HAI titre antibody boosting and waning. We applied the model to derive population-level and individual effects of post-vaccine antibody kinetics for A(H1N1) and A(H3N2) influenza subtypes. We found that post-vaccine HAI titre dynamics were significantly influenced by pre-vaccination HAI titre and vaccination history and that lower pre-vaccination HAI titre results in longer durations of seroprotection (HAI titre equal to 1:40 or higher). We also observed that the effect of vaccination history on antibody boosting was stronger for egg-grown A(H1N1) vaccinating strains in individuals with higher pre-vaccination HAI titres, whereas this effect diminished for egg-grown A(H3N2) vaccinating strains. Consequently, for cell-grown A(H1N1), our inference finds that the expected duration of seroprotection post-vaccination was 171 (95 % Posterior Predictive Interval[PPI] 128-220) and 159 (95 % PPI 120-200) days longer for those who are infrequently vaccinated (<2 vaccines in last five years) compared to those who are frequently vaccinated (2 or more vaccines in the last five years) at pre-vaccination HAI titre values of 1:10 and 1:20 respectively. In addition, we found significant differences in the empirical distributions that describe the individual-level duration of seroprotection for A(H1N1) cell-grown strains. In future, studies that rely on serological endpoints should include the impact of pre-vaccine HAI titre and prior vaccination status on seropositivity and seroconversion estimates, as these can significantly influence an individual's post-vaccination antibody kinetics., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sheena Sullivan reports a relationship with Seqirus Australia Pty Ltd. that includes: consulting or advisory. Sheena Sullivan reports a relationship with Moderna Inc. that includes: consulting or advisory. Sheena Sullivan reports a relationship with Pfizer Inc. that includes: consulting or advisory. Sheena Sullivan reports a relationship with Evolution Health that includes: consulting or advisory. Annette Fox reports a relationship with Sanofi that includes: consulting or advisory. Annette Fox reports a relationship with Evidera that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Clinical risk factors of deficient immune responses to COVID-19 mRNA vaccination in SARS-CoV-2 naive hemodialysis recipients (HDR) have already been identified. Clinical factors influencing hybrid immunity induced by SARS-CoV-2 infection and vaccination in HDR have not been reported., Methods: A comprehensive analysis of antibody (Ab) and T cell responses to two doses of BNT162b2 mRNA vaccination was performed in 103 HDR, including 75 SARS-CoV-2 naive and 28 experienced patients, and in 106 healthy controls (HC) not undergoing HD, including 40 SARS-CoV-2 naive and 66 experienced subjects. Clinical risk factors associated with lower humoral and cellular immunity were analyzed in SARS-CoV-2 naive and experienced HDR by univariate and multivariate analyses., Results: Naive HDR had lower neutralizing and non-neutralizing antibody responses to vaccination than naive HC; lower vaccine responses were correlated with previous transplantation, immunosuppressive treatment, corticosteroid treatment, hypoalbuminemia, older age, hypertension, and negative response to hepatitis B vaccination. In contrast, vaccine responses of SARS-CoV-2 experienced HDR were similar to those of HC and were correlated with time between infection and vaccination and with previous transplantation, but not with the other risk factors associated with lower vaccine responses in naive HDR., Conclusion: COVID-19 vaccine responses are influenced by distinct risk factors in SARS-CoV-2 naive and experienced HDR. These observations have important implications for the understanding of vaccine-induced immunity and for the management of this vulnerable patient population., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Nicolas Gemander reports financial support was provided by Sciensano. Margaret Ackerman reports financial support was provided by US NIAID (grants R56AI165448 and P01AI162242). Margaret Ackerman reports financial support was provided by NIH NIGMS. Margaret Ackerman reports financial support was provided by Bill and Melinda Gates Foundation. Margaret Ackerman reports financial support was provided by SD Ireland Foundation. Margaret Ackerman reports equipment, drugs, or supplies was provided by Johns Hopkins Universities. Margaret Ackerman reports article publishing charges was provided by Elsevier. Margaret Ackerman reports financial support was provided by Seromyx systems. Margaret Ackerman reports financial support was provided by Keystone Conferences. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Understanding how the efficacy of COVID-19 vaccines translates from clinical trials to real-world settings is critical to inform evolving vaccination policies. The objective of this study was to assess COVID-19 vaccine effectiveness (VE) against severe COVID-19-related outcomes in children aged 5-11 years, including COVID-19-related hospital admissions and multisystem inflammatory syndrome in children (MIS-C)., Methods: We conducted a retrospective, population-based cohort study using linked health administrative data in the first year following the emergence of the Omicron variant (January 2 to December 31, 2022) in Ontario, Canada. Baseline differences between subgroups of interest were compared using standardized differences. We used multivariable Cox proportional hazard regression models to estimate VE by time since last vaccine dose by treating vaccination as a time-varying exposure, compared to unvaccinated children., Results: We included a total of 1,058,740 children, of which 583,867 (55.1 %) had received at least one vaccine dose by the end of the study period. In total, there were 185 COVID-19-related hospital admissions and 39 cases of MIS-C. The rate of COVID-19-related admission was substantially higher in children with an underlying comorbid condition compared to children who were previously healthy (adjusted hazard ratio [aHR] = 4.77, 95 %CI, 3.56-6.38). VE against COVID-19-related admission ranged from 93 % (95 %CI, 52-99 %) 7-29 days after a second dose to 63 % (95 %CI; 41-77 %) ≥120 days after a second dose. There was no statistically significant difference in the rate of MIS-C in children who received at least one dose of the vaccine compared to unvaccinated children (aHR = 0.71; 95 %CI, 0.38-1.34)., Conclusions: We found that, for children aged 5-11 years, VE against COVID-19-related hospitalization was high in the first four months after a second dose. Children with comorbid conditions were found to be at much higher risk of COVID-19-related severe outcomes and thus may benefit most from COVID-19 vaccination., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jeffrey C. Kwong reports financial support was provided by Canadian Institutes of Health Research. Jeffrey C. Kwong reports financial support was provided by Public Health Agency of Canada. Kumanan Wilson reports a relationship with CANImmunize that includes: board membership. Shaun K. Morris reports a relationship with GlaxoSmithKline that includes: consulting or advisory and speaking and lecture fees. Shaun K. Morris reports a relationship with Sanofi Pasteur that includes: consulting or advisory and speaking and lecture fees. Shaun K. Morris reports a relationship with Pfizer that includes: consulting or advisory and speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Respiratory syncytial virus (RSV) is a leading cause of infant respiratory disease. Recent approval of preventive measures like a long-acting monoclonal antibody and a maternal vaccine signals a potential shift in early-life RSV infection control. However, success hinges on acceptance., Methods: We conducted a cross-sectional survey among pregnant women and partners in the Netherlands, recruited via healthcare professionals, social media platforms, and the 9-Months Fair. The survey assessed willingness and motivation for maternal RSV vaccination and neonatal RSV immunization, including strategy preferences and informational needs., Results: In total 1001 pregnant women (mean age: 31.1 years) and their partners (mean age: 33.2 years) completed the survey. On average, they were 24 weeks pregnant at the time, and 54.6 % had no other children yet. The majority was Dutch-born (95.2 % of women); with 68.3 % of women having completed higher education and with overall strong pro-vaccination attitudes (93.9 % of partners intended to vaccinate their expected newborn). The overall acceptability to vaccination and immunization was high, with 87 % of respondents indicating they would (likely) accept both strategies. A positive attitude towards both methods was associated with previous experience with severity of RSV, intention to vaccinate the newborn and parental vaccination status during childhood and current pregnancy. When the choice was given, the majority of participants, in particular those with children and the intention to breastfeed, favoured maternal vaccination over passive immunization of infants (75.3 % of the pregnant and 71.6 % of the partners). A majority of the respondents cited optimal protection for the child and knowledge of RSV as important factors for accepting RSV prophylaxis., Conclusions: While most participants would accept both strategies for RSV protection of their infant, a majority, especially those with other children, favoured maternal vaccination, due to concerns about infant safety and awareness of RSV severity., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Objective: To estimate the effectiveness of several vaccine brands-Pfizer, Astra, and Sinovac-against symptomatic COVID-19 without information on vaccination at the individual level., Methods: We use data of mass vaccination programs-specifically, for sexagenarians and quinquagenarians-in three large municipalities of Mexico (Monterrey, Guadalupe, and San Nicolás) to conduct a two-step time series estimation procedure involving a synthetic control group. The data covers the period between the first week of March 2020 and the first week of October 2021., Results: Vaccine effectiveness is a concave function of time. At the peak, Pfizer reaches 92.6 % effectiveness, Astra 83.6 % and Sinovac 65.6 %. This occurs 9 to 12 weeks after the first shot., Conclusion: The results indicate that the three vaccines protect against symptomatic COVID-19. Nevertheless, they offer different levels of protection. The results also suggest that VE-under a two-shot scheme-reaches its peak 9 to 16 weeks after the first shot. Moreover, there seems to be a trade-off between achieving higher efficiency by administering the 2nd shot earlier or extending the protection period by administering it later., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: It is crucial to emphasize the necessity of annual COVID-19 vaccination, particularly for vulnerable populations like older and chronically ill individuals., Objectives: This study aimed to quantify the level of vaccination acceptance and its 5C psychological antecedents in the South Korean and Chinese populations and also to identify the predictors, considering contextual variations that influence vaccine acceptance in both countries., Methods: A cross-sectional survey study was undertaken in South Korea and China between March 15 and March 30, 2023, coinciding with the emergence of the SARS-CoV-2 Omicron variant in both nations. The study comprised 1000 participants from South Korea and 3000 participants from China. A chi-square analysis, t-tests and multivariable logistic regression analysis were employed to evaluate the factors influencing the acceptance of COVID-19 vaccines., Results: A higher degree of vaccine acceptance was observed among Chinese participants (48.5 %), in contrast to the 16.8 % among South Koreans. Analyzing the psychological antecedents for vaccination, the Chinese cohort showed high vaccine confidence, whereas South Koreans had increased constraint perceptions. Psychological antecedents, particularly Confidence, play a significant positive role in vaccine acceptance in both South Korea (OR 2.98, CI [2.26-4.01], p < 0.001) and China (OR 2.93, CI [2.58-3.33], p < 0.001), while Constraints in South Korea (OR 0.83, CI [0.69-0.99], p < 0.05) and China (OR 0.86, CI [0.79-0.94], p < 0.001) contribute negatively to vaccine acceptance. Notably, divergent trends in the impact of age and underlying health conditions on vaccine acceptance were observed., Conclusions: This study reveals a substantial disparity in acceptance, psychological antecedents, and predictors of vaccine acceptance between China and South Korea. This importance of understanding contextual factors influencing public vaccine acceptance is emphasized. There is an urgent need for robust vaccination strategies that boost confidence and alleviate constraints to COVID-19 vaccination, which should be tailored to the unique contextual factors of each country., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Lassa fever is a serious epidemic viral disease in West Africa affecting an estimated 2 million people annually with about 5000-10,000 deaths, although supporting data is sparse. Lassa fever significantly affects neonates, children, and pregnant women, however, comprehensive data on its impact in these populations are lacking. We reviewed the available literature on Lassa fever to assess its prevalence and impact in these populations and implications for vaccine development. Clinical features in children were similar to those observed in adults, with complications such as bleeding. Altered mental status, anasarca (swollen baby syndrome), bleeding, and poor urine output were risk factors for death. The case fatality rate (CFR) in 16 paediatric studies ranged from 6 % to 63 % and was 66.7 % and 75.0 % in two neonatal studies. In a systematic review of studies on pregnant women the CFR was 33.73 %. The adverse foetal outcomes included miscarriage, stillbirth, and intrauterine death associated with maternal death. Since Lassa fever significantly affects neonates, children, and pregnant women, developing a safe and effective, single-dose vaccine for these high-risk populations is vital. Currently, there are four clinical trials assessing Lassa virus vaccines. Only one of these trials is enrolling children aged ≥18 months, and exclude pregnant and breast-feeding women. It is essential that pregnant and breast-feeding women and young children are included in clinical trials that incorporate robust safety surveillance and risk mitigation measures. In our review, potential approaches to address the specific gaps in the areas of diagnosis, management, and prevention of Lassa fever in these specific populations, such as disease surveillance systems and vaccine development, were identified. A comprehensive strategy with investment focused on addressing specific knowledge gaps will be essential in protecting the health of these specific populations in Lassa virus endemic regions., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Flor M Munoz reports financial support, administrative support, article publishing charges, and writing assistance were provided by Coalition for Epidemic Preparedness Innovations. Clare L Cutland reports a relationship with Pfizer that includes: funding grants. Clare L Cutland reports a relationship with BMGF that includes: funding grants. Clare L Cutland reports a relationship with GIZ that includes: funding grants. Flor M. Munoz is an associate editor for Vaccine. Helen Marshall declared being an investigator on vaccine clinical trials with institutional funding by pharmaceutic industry with no personal payments If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Vaccines are effective and affordable health prevention measures to prevent vaccine-preventable diseases, but achieving sufficient vaccine uptake population-wide is challenging. In this work, we assess the impact of various text messages reminders on COVID-19 booster uptake and the extent to which the effect of messages holds over time. Additionally, we analyse whether people's self-reported vaccination intentions (measured in response to message prompts) corresponds to actual vaccine uptake and whether this relationship differs between message variants., Methods: We performed two large sequential randomized controlled trials (RCTs) in the Netherlands (N = 140.973), with the design of RCT2 building on the findings of RCT1. We 1) analyzed the effect of various text messages on COVID-19 booster uptake; 2) assessed the extent to which these effects hold over time; and 3) tested whether a positive response to message prompts moderates the effect of message variant on vaccine uptake., Results: First, the results of RCT1 demonstrate that text messages with an ownership frame ("your [vaccine] is ready for you") result in highest vaccine uptake (e.g., compared to no text message: OR = 1.28 [99 % CI 1.03-1.59]). RCT2 showed that text messages with an ownership frame and a specific date, time and location result in highest vaccine uptake (e.g., compared to no text message: OR = 2.10 [99 % CI 1.85-2.38]). Second, most message effects hold over a longer period of time (e.g., 'date, time, location' message versus no message: OR = 2.10 [99 % CI 1.85-2.38] on day 6 and OR = 1.36 [99 % CI 1.25-1.48] on day 50). Third, we find that participants who received our most effective text and replied that they will take the vaccine, are more inclined to actually take the vaccine compared to the message with broad opening hours OR = 2.86 [99 % CI 2.14-3.82]., Conclusion: Text message reminders are able to increase vaccine uptake. From the tested variations, messages with an ownership frame providing a specific date, time and location are most effective. Because text messages demonstrate no notable disadvantages, we advise Public Health authorities to include this effective intervention in their vaccination campaign strategies., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Vaccine hesitancy is an urgent public health threat. While tools have been developed to monitor vaccine hesitancy among parents and the general adult population, no such tool exists for adolescents., Methods: We modified an existing adult Vaccine Hesitancy Scale to create a teen COVID-19 Vaccine Hesitancy Scale (tVHS-COVID) for adolescents and their parents. To validate our scale, we conducted a nationally representative survey of 764 parent-teen dyads. We performed exploratory factor analysis (EFA) to determine the factor structure followed by confirmatory factor analysis (CFA) to test the factor structure validity using two random subsets. We evaluated internal consistency by Cronbach alpha values and construct validity by comparing tVHS-COVID scores to intention to receive future COVID-19 doses., Results: EFA suggested a three-factor structure with 13-items. CFA indicated good fit for adolescents (CFI = 1.00; RMSEA = 0.023; SRMR = 0.062; NNFI-TLI = 0.998) and for parents (CFI = 1.00, RMSEA = 0.031; SRMR = 0.028; NNFI-TLI = 1.00). Internal consistency exceeded 0.79 for adolescents and 0.78 for parents. As tVHS-COVID scores increased, the percent of adolescent and parent respondents who reported they were willing to receive a COVID-19 vaccine decreased., Discussion: The tVHS-COVID offers a unique tool that can be used to monitor COVID-19 vaccine hesitancy among adolescents and their parents. As adolescents take on more proactive roles in medical decision-making, monitoring vaccine hesitancy among this population becomes increasingly important., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Annette Regan reports financial support was provided by National Institutes of Health. Annette Regan reports a relationship with Moderna Inc that includes: board membership. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: The Inflation Reduction Act (IRA) eliminated cost sharing for Medicare Part D-covered vaccines but did not address the cost burden faced by Medicare beneficiaries who did not have prescription drug coverage. This study aimed to determine the characteristics of beneficiaries without prescription drug coverage and to assess the association between the receipt of a herpes zoster vaccine and prescription drug coverage status., Methods: We used the 2019-2023 National Health Interview Survey and included Medicare beneficiaries aged 65 years and older who enrolled in both Parts A and B or a Medicare Advantage plan. Descriptive statistics were used to examine beneficiaries' characteristics. Logistic regressions were used to examine the associations between the receipt of a herpes zoster vaccine and Medicare prescription drug coverage., Results: The study included 33,578 beneficiaries and 93.5 % of beneficiaries had prescription drug coverage. The prevalence of lacking prescription drug coverage was higher among beneficiaries who did not have a college degree, had family income below the poverty level, had no flu shot and well visit within the past year, and had no usual place for care. The probability of receiving a herpes zoster vaccine was higher among beneficiaries with prescription drug coverage than those without prescription coverage (45.2 % versus 25.3 %)., Conclusions: Herpes zoster vaccination disparities between beneficiaries with and without prescription drug coverage existed before the IRA. Because the IRA only addresses the cost barrier facing by beneficiaries with prescription drug coverage, vaccination disparities was greater after the IRA implementation., Competing Interests: Declaration of competing interest The authors assure that no funding was given to produce this study and have no financial relationships relevant to this study and no conflicts of interest to disclose. The authors assure that no funding was given to produce this study and have no financial relationships relevant to this study and no conflicts of interest to disclose. The findings and conclusions of this paper are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention., (Published by Elsevier Ltd.)

Background: Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination., Methods: This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe. In stage 1, healthy MenACWY vaccine-naive or -experienced 10- to 25-year-olds were randomized 1:2 to receive MenABCWY and placebo or MenB-fHbp and MenACWY-CRM. Eligible participants were randomly selected to participate in stage 2, which was an open-label immunopersistence and booster extension. Immunogenicity was assessed through serum bactericidal antibody using human complement (hSBA) assays with serogroups A/C/W/Y (MenA/C/W/Y) and 4 primary serogroup B (MenB) test strains. Immunogenicity endpoints included hSBA seroprotection rates through 48 months after primary vaccination and 1 month after the booster. Safety endpoints included booster reactogenicity events and adverse events (AEs)., Results: Of 1379 eligible participants, 353 entered stage 2; 242 completed the 48-month blood draw after primary vaccination and 240 completed the booster vaccination phase. MenA/C/W/Y seroprotection rates remained high for 4 years following a 2-dose MenABCWY primary series (MenACWY-naive, 62.0 %-100.0 %; MenACWY-experienced, 98.7 %-100.0 %) and trended higher than those after a single MenACWY-CRM dose (MenACWY-naive, 38.1 %-95.2 %; MenACWY-experienced, 89.7 %-100.0 %). Corresponding seroprotection rates against MenB remained stable and generally higher than baseline (MenABCWY, 18.2 %-36.6 %; MenB-fHbp, 16.2 %-31.9 % across strains). Following a booster, seroprotection rates against all 5 serogroups were ≥ 93.8 % across groups. Most booster dose reactogenicity events were mild or moderate in severity, and AEs were infrequent., Conclusions: Immune responses remained high for MenA/C/W/Y and above baseline for MenB through 4 years after the MenABCWY primary series, with robust responses for all 5 serogroups observed following a booster. The MenABCWY booster had an acceptable safety and tolerability profile consistent with the primary series. NCT03135834., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. James Peterson reports a relationship with Pfizer Inc. that includes: funding grants. Dr. Daniel Drazab reports a relationship with Pfizer Inc. that includes: funding grants. Dr. Beth Moughan reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Jason D. Maguire reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Lefteris Zolotas reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Roger Maansson reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Robert O'Neill reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Paula Payrani reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Luis Jodar reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. William C. Gruber reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Annaliesa S. Anderson reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. Dr. Johannes Beeslaar reports a relationship with Pfizer Inc. that includes: employment and equity or stocks. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Pfizer Inc. Published by Elsevier Ltd.. All rights reserved.)

Purpose: In Australia, adolescents are scheduled to receive vaccinations against diphtheria, tetanus, pertussis, human papillomavirus, and meningococcal disease, delivered via school vaccination programs and general practitioners (GPs). Public health measures implemented in response to the COVID-19 pandemic impacted uptake of some adolescent age-based vaccinations. Limited information is available on parents' approaches to vaccinating their adolescent children during the pandemic. We aimed to explore parents' experiences of adolescent age-based vaccinations during the pandemic, and factors they perceived as hindering or facilitating vaccination., Methods: In July 2022 we recruited 21 Australian parents of adolescent children eligible for age-based vaccinations in 2021. We recruited from metropolitan and regional settings, and from states where uptake was most and least affected by pandemic disruptions. We conducted 30-min virtual or phone interviews and analysed the data thematically., Results: Parents described how experiences before and during the COVID-19 pandemic influenced their perspectives on and experiences with adolescent age-based vaccinations. Motivation to vaccinate their children was informed by personal beliefs and experiences with the healthcare system. Parents described practical issues, including ease of access to the school vaccination program or a GP, and knowledge about vaccination schedules and services. Parents suggested enhancing promotion of adolescent vaccination benefits and information sharing, and recommended improving access to vaccination services outside the school program., Discussion: Findings have potential to improve delivery of adolescent age-based vaccinations, including during future pandemics. While this study was conducted in the Australian context, findings and recommendations have relevance to overseas adolescent age-based vaccination programs., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Pertussis vaccination in young mothers aims to protect neonates through cocooning. We estimated pertussis vaccination coverage (VC) in women at two months postpartum in France in 2021, and the proportion of women who got vaccinated in the first two months postpartum; associated determinants were studied., Methods: We used data from the 2021 National Perinatal Surveys conducted in metropolitan France (ENP 2021) and French overseas territories (ENP-DROM 2021). Multivariate poisson regressions were employed to study the following determinants: age, educational level, monthly household income, socio-professional situation, birth country, parity, health professional who monitored pregnancy, influenza vaccination during pregnancy, region of residence, prenatal care consultations, having health insurance, having a partner, and having a chronic pathology. Results were weighted., Results: The study sample comprised 7999 women. Estimated pertussis VC at two months postpartum was 66.8 % (95 %CI [65.5-68.0]). VC was significantly lower in i) unemployed women (vs. executives/managers, intermediate and higher intellectual professionals), ii) those on low income (vs. high), and iii) those with two or more children (vs. primiparous). It was significantly higher in i) women born in France, ii) those vaccinated against influenza during pregnancy, iii) those who received pre-natal care from a private midwife, and iv) those with more prenatal consultations. The proportion of women vaccinated against pertussis in the two-month postpartum period (33.4 % [31.7-35.9]) was significantly lower in i) women on low incomes, ii) unemployed women, iii) women with health insurance, and iv) multiparous women. It was significantly higher in those vaccinated against influenza during pregnancy., Discussion - Conclusion: Pertussis VC in women at two months postpartum in 2021 was insufficient and was marked by social and territorial inequalities in health. Vaccination for pregnant women has been recommended in France since 2022. A study monitoring the impact of this new recommendation is essential., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that might influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Achieving the ambitious goals of the Immunisation Agenda 2030 (IA2030) requires a deeper understanding of factors influencing under-vaccination, including timely vaccination. This study investigates the demand- and supply-side determinants influencing the timely uptake of key childhood vaccines scheduled throughout the first year of life in The Gambia., Methods: We used two nationally-representative datasets: the 2019-20 Gambian Demographic and Health Survey and the 2019 national immunisation facility mapping. Using Bayesian multi-level binary logistic regression models, we identified key factors significantly associated with timely vaccination for five key vaccines: birth dose of hepatitis-B (HepB0), first, second, and third doses of the pentavalent vaccine (Penta1, Penta2, Penta3), and first-dose of measles-containing vaccine (MCV1) in children aged 12-35 months. We report the adjusted Odds Ratios (aORs) and 95 % Credible Intervals (95 % CIs) in each case., Results: We found that demand-side factors, such as ethnicity, household wealth status, maternal education, maternal parity, and the duration of the household's residency in its current location, were the most common drivers of timely childhood vaccination. However, supply-side factors such as travel time to the nearest immunisation clinic, availability of cold-storage and staffing numbers in the nearest immunisation clinic were also significant determinants. Furthermore, the determinants varied across specific vaccines and the timing of doses. For example, delivery in a health facility (aOR = 1.58, 95 %CI: 1.02-2.53), living less than 30 min (aOR = 2.11, 95 %CI: 1.2-8.84) and living between 30 and 60 min (aOR = 3.68, 95 %CI: 1.1-14.99) from a fixed-immunisation clinic was associated with timely HepB0, a time-sensitive vaccine that must be administered within 24 h of birth. On the other hand, children who received Penta1 and Penta2 on time were three- to five-fold more likely to receive subsequent doses on time (Penta2 and Penta3, respectively). Finally, proximity to an immunisation facility with functional vaccine cold-storage was a significant supply-side determinant of timely MCV1 (aOR = 1.4, 95 %CI: 1.09-1.99)., Conclusions: These findings provide valuable insights for programme managers and policymakers. By prioritising interventions and allocating scarce resources based on these identified determinants, they can maximize their impact and ensure children in The Gambia receive timely vaccinations throughout their first year of life, contributing to IA2030 goals., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Oghenebrume Wariri reports financial support was provided by European and Developing Countries Clinical Trials Partnership. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

To identify the best method of distributing vaccine baits for animals, the oral vaccine Flc-LOM-BE rns was buried or placed directly on the ground within a mountainous area measuring 163 ha. Wild boars were observed more often around sites where the oral vaccine was buried than around sites where the oral vaccine was placed directly on the ground. Only wild boars consumed both the bait and the vaccine formulation. To confirm whether the Flc-LOM-BE rns vaccine strain has DIVA function, it was spread or buried within a mountainous area of 2.3 ha that was frequented by grazing hybrid-wild boars. Among the 15 hybrid-wild boars captured before consuming the oral vaccine, two were positive for anti-CSFV E2, but negative for anti-BVDV E rns antibodies. The CSFV E2 and BVDV E rns antibody positivity rates in 46 hybrid-wild boars captured 6 weeks after distributing the oral vaccine were 56.5 % (26/46, 95 % CI: 42.2-69.7) and 52.1 % (24/46, 95 % CI: 38.1-65.8), respectively. However, the CSFV E2 and BVDV E rns antibody positivity rates at 28 weeks post-distribution of the oral vaccine decreased by 10.3 % and 13.7 %, respectively, when compared with those in hybrid-wild boars captured after 6 weeks. Since the antibody positivity rates induced by the oral vaccine decreased after 7 months, it is necessary to distribute the oral vaccine at least twice a year (early spring and late fall)., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dong-Jun An reports financial support was provided by Animal and Plant Quarantine Agency. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) was formed to evaluate the safety and other key features of new platform technology vaccines. This manuscript provides an overview of Modified Vaccinia virus Ankara (MVA)-vectored vaccines and reviews molecular and biological key features of this platform. In particular, this review aims to provide fundamental information about the promising candidate vaccine MVA-MERS-S which has been evaluated successfully in different preclinical animal models and has undergone clinical testing including a phase Ib study involving more than 170 participants. Infectious diseases continue to be a major cause of human death worldwide. In this context, emerging zoonotic infectious diseases pose a particular challenge for public health systems. In the last two decades, three different respiratory coronaviruses, including the Middle East respiratory syndrome Coronavirus (MERS-CoV) have emerged. For many years, safe and efficacious vaccines have been a major tool to combat infectious diseases. Here, we report on a promising candidate vaccine (MVA-MERS-S) against MERS-CoV based on MVA. Upon application, MVA-MERS-S has been well tolerated and immunogenic, inducing both, cellular and humoral immune responses in different animal models and humans. We demonstrate that the MVA vector platform, with the example of MVA-MERS-S, is a viable and effective tool for producing safe, immunogenic, and efficient vaccines against emerging infectious diseases., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The severity of SARS-CoV-2 illness is influenced by factors including age, sex, pre-existing health conditions, and individual immune responses. However, the mechanisms conferring immunity following antigenic challenge have not been fully elucidated. There are currently no studies evaluating longitudinal proteomic changes in individuals following vaccination and breakthrough, limiting our understanding of the underlying mechanisms driving conferred immunity. In this work, we evaluated the differential protein expression in individuals with (CoV-P) or without (CoV-N) prior SARS-CoV-2 infection following primary vaccination and after breakthrough infection (CoV-BT). Overall, we found that individuals receiving primary vaccination relied on innate immune mechanisms, including complement and coagulation cascades, and natural killer cell-mediated cytotoxicity, while conversely, breakthrough infection immune mechanisms relied on T cell-mediated immunity. These mechanistic differences may help explain heterogeneity associated with vaccine-induced and breakthrough infection-related outcomes., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Florian Krammer reports financial support was provided by Icahn School of Medicine at Mount Sinai. Savita Pahwa reports financial support was provided by University of Miami Miller School of Medicine. Florian Krammer reports a relationship with Icahn School of Medicine at Mount Sinai that includes:. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: During the COVID-19 pandemic, vaccination centers were established to achieve widespread immunization of the public within a short time. This may, however, have come at the cost of customer experience. This study analyzes factors related to the special characteristics of service experiences in COVID-19 vaccination centers and their impact on expectation confirmation as a driver of future vaccination intentions., Methods: Our analysis is based on data from an online survey among clients of a vaccination center in Switzerland receiving a second dose of COVID-19 vaccines between May and September 2021 (n = 3192). Using a structural equation model, we analyzed the impact of perceived competence, informed consent, safety beliefs, privacy perceptions, and warmth on service experience and expectation confirmation., Results: Perceived competence (path coefficient [p.c.] 0.199 95 % confidence interval [CI] 1.123-0.288), safety beliefs (p.c. 0.124, 95 % CI 0.070-0.178), privacy perceptions (p.c. 0.226, 95 % CI 0.162-0.299), and warmth (p.c. 0.286, 95 % CI 0.180-0.381) have a direct positive effect on service experience, which in turn has a positive effect on expectation confirmation (p.c. 0.313, 95 % CI 0.246-0.380). The quality of the informed consent discussion (p.c. 0.071, 95 % CI -0.001-0.145) between vaccinating health professional and customer had no effect on service experience. The effect size (f2) of warmth (f2 0.089, 95 % CI 0.180-0.381), and privacy perceptions (f2 0.060, 95 % CI 0.162-0.299) on service experience was higher than that for perceived competence (f2 0.041, 95 % CI 0.123-0.288) and safety beliefs (f2 0.020, 95 % CI 0.0.07-0.178)., Conclusions: The service experience in vaccination centers is related to expectation confirmation, which can enhance the likelihood of future revaccination. When planning vaccination center operations, attention should be paid to providing a comfortable and service-friendly environment for clients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

In recent years, fowl adenovirus (FAdV)-induced diseases became a global problem with considerable impact on chicken health and welfare. This has prompted numerous studies to focus on experimental immunization strategies using whole virus formulations (live or killed vaccines), some of them modified as recombinantly constructed vector vaccines. In addition, FAdV capsid proteins were frequently reported as immunizing antigens (subunit vaccines), with fiber proteins being amongst the most successful candidates. To date, there is no standardized protocol to assess vaccine efficacy in experimental FAdV protection studies, with the consequence that the experimental settings present several degrees of variations even when sharing similar premises. Differences in formulation preparations, route of inoculation, antigen dose, vaccination scheme, choice of challenge strain, or type and age of the birds are capable to greatly influence the magnitude of the immune response and the consequent protective efficacy, altogether addressing remaining challenges. Beyond the antigen composition of a vaccine, the epidemiology of FAdVs with the potential of vertical transmission of virus and/or antibodies from breeders to progenies has a substantial impact on protection strategies. The goal of this review is to outline a broad overview of the findings made thus far regarding immunization strategies against diseases associated to FAdV infections, considering the literature published since the appearance of hepatitis-hydropericardium syndrome (HHS) in the late Eighties, in order to emphasize the current knowledge on FAdV vaccines and highlight fields of future research and intervention., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Research examining the relationship between psychological factors and COVID-19 vaccine hesitancy has been mostly based on observational designs, with little attention devoted to the role of exposure to objective/sensationalist information., Purpose: This experimental study examined the extent to which exposure to objective or sensationalist news headlines: 1) influenced COVID-19 anti-vaccination attitudes; and 2) moderated the relationship between psychological factors and COVID-19 anti-vaccination attitudes., Methods: 123 participants (mean age = 28.55, SD = 11.44) completed measures of psychological factors previously associated with vaccine hesitancy (i.e. social norms regarding COVID-19, adherence to non-pharmaceutical interventions (NPIs), perceived health competence, trust in complementary and alternative medicine (CAM), COVID-19 conspiracy beliefs, and COVID-19 risk perception). Next, participants were randomly assigned to view nine print news headlines about COVID-19 vaccines that were depicted in objective or sensationalist terms. Finally, participants completed a measure of COVID-19 anti-vaccination attitudes. A t-test and simple slope analyses were performed to assess whether there were group differences in COVID-19 anti-vaccination attitudes between participants exposed to objective or sensationalist information, and whether exposure to objective or sensationalist information moderated the relationship between psychological factors and COVID-19 anti-vaccination attitudes, respectively., Results: Participants exposed to sensationalist news headlines reported stronger COVID-19 anti-vaccination attitudes than those exposed to objective headlines. Exposure to objective or sensationalist news headlines moderated the relationship between several psychological factors (i.e. adherence to NPIs, perceived health competence, and trust in CAM) and COVID-19 anti-vaccination attitudes., Conclusions: The results highlight that a joint focus on psychological factors and exposure to objective/sensationalist information may contribute to gain a better understanding of vaccine hesitancy in the context of the COVID-19 infodemic., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

In this study, we developed two plasmid constructs, pJHL270 and pJHL305, for the dual expression of Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV) Gn and Gc glycoproteins in both prokaryotic and eukaryotic systems. The constructs feature a prokaryotic expression controlled by the Ptrc promoter and a eukaryotic expression driven by the cytomegalovirus promoter and Semliki Forest Virus RNA-dependent RNA polymerase. The Gn/Gc antigenic epitope was derived from consensus sequences of 12 SFTSV M segments collected in South Korea and designed for optimal antigen expression. The full antigen was expressed eukaryotically for post-translational modifications, while the epitope construct was expressed prokaryotically. These constructs were electroporated into an attenuated Salmonella Typhimurium strain (JOL2500) for plasmid delivery, resulting in JOL3042 and JOL3045. Successful expression was confirmed via qRT-PCR and western blot analysis. Mice immunized with JOL3042 showed antibody responses as early as two weeks, while JOL3045 elicited responses at six weeks, skewed toward a Th1 response initially, later balancing with Th2. Flow cytometry revealed significant CD3 + CD4 + and CD3 + CD8 + T-cell responses. Both constructs generated neutralizing antibodies, and a challenge study indicated significant reductions in viral loads in the serum, liver, and spleen of vaccinated mice, demonstrating the effectiveness of the Salmonella-mediated delivery system against SFTSV infection. The outcome of the current study may pave the way to develop a safer and more effective Salmonella-mediated vaccine against lethal SFTSV infection in vulnerable populations., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: John Hwa Lee reports financial support was provided by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (2019R1A6A1A03033084 and 2022R1A6A3A01086797). John Hwa Lee reports a relationship with Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Zika virus (ZIKV) infection is primarily transmitted by mosquitoes and often asymptomatic in most individuals. Infection during pregnancy can lead to severe birth defects such as congenital microcephaly, and currently, there is no approved vaccine for ZIKV. Several studies are investigating the development of ZIKV vaccine using DNA and RNA as well as recombinant protein technologies; however, the outcomes thus far have not been consistently noteworthy. In this study, we designed an mRNA vaccine for ZIKV and evaluated its immunogenicity using a mouse model. Our vaccine, termed 3xEIII, encodes a triple repeat of domain III from the ZIKV E protein. We effectively encapsulated the mRNA within lipid nanoparticles (LNPs), administered 3xEIII to mice via two intramuscular injections, and assessed the induced humoral and cellular immune responses. Specifically, the vaccine elicited neutralizing antibodies that effectively eliminated ZIKV from the organs of challenged mice. Notably, 3xEIII conferred both protective effects and long-term immunity. In subsequent challenges conducted 40 weeks after boosting, immunized mice experienced temporary weight loss but showed significantly reduced viral titers in target organs by the 9th day post-infection. Conclusively from these findings, 3xEIII stands out as a promising noteworthy mRNA vaccine candidate for Zika virus., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

The recent entry of multiple vaccines targeting Neisseria gonorrhoeae (Ng) into the clinical development pathway has highlighted the need to establish methods of adequately assessing anti-gonococcal immune responses. Serum bactericidal activity (SBA) is utilized as a measurement of efficacy in licensure of meningococcal vaccines, but the importance of functional antibodies in preventing and/or clearing gonococcal infections remains largely unknown. In an effort to elucidate the utility of SBA as an immune correlate of protection, we sought to develop a standardized high-throughput human complement SBA (hSBA) assay for which any strain of interest could be tested under uniform conditions, with minimal screening of complement required. Utilization of IgG/IgM-depleted pooled human complement serum permitted testing of diverse serum resistant and sensitive gonococcal and unencapsulated meningococcal strains when bacteria were cultured to induce lipooligosaccharide sialylation; only one of nine randomly selected lots demonstrated intrinsic toxicity. The hSBA assay was well suited for use with multiple test serum sources, including rabbit, mouse, and human serum samples, suggesting widespread applicability., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brian Bonk, Chris Lyle and Bob Natuk report a relationship with Pel-Freez Biologicals that includes employment. Brian Bonk reports a relationship with Pel-Freez Biologicals that includes board membership, equity and stock. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Foot-and-mouth disease (FMD), a viral infection affecting cloven-hoofed animals, persists as an endemic challenge worldwide, causing significant economic losses. Vaccination is a pivotal strategy for disease control, especially in endemic regions where it may be the sole option. In FMD-free countries, "vaccination to cull" strategies are increasingly considered to prevent disease spread. Concurrently, the coexistence of FMD with other animal diseases in endemic regions raises the prospect of simultaneous or combined administration of multiple vaccines for cost, labor, and animal welfare benefits. We conducted a narrative review to investigate the positive or negative effects of concurrent FMD vaccination with other viral and bacterial vaccines. For this purpose, the literature is organized chronologically. Duplicate sources were eliminated, and older sources without sufficient data were excluded. Studies only those targeting the specific species were included. This comprehensive review synthesizes findings from over 50 years of research, offering insights applicable in the ongoing fight against endemic diseases and inspiring innovative approaches., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection globally, and a vaccine is urgently needed to stop transmission and disease. Chlamydial Protease Activity Factor (CPAF) is an immunoprevalent and immunodominant antigen for CD4 T cells and B cells, which makes it a strong vaccine candidate. Due to the tolerogenic nature of the female genital tract (FGT) and its lack of secondary lymphoid tissue, effective induction of protective cell-mediated immunity will likely require potent and safe mucosal adjuvants. To address this need, we produced CPAF in a cell-free protein synthesis platform and adjuvanted it with the TLR9-agonist CpG1826, a synthetic cyclic-di-AMP (CDA) STING (stimulator of interferon genes) agonist ADU-S100, and/or the squalene oil-in-water nanoemulsion, AddaS03. We determined that intranasal immunization with CPAF plus ADU-S100 was well tolerated in female mice, induced CD4 T cells characterized by TNFα production alone or in combination with IL-17 A or IFNγ, significantly reduced bacterial shedding, and shortened the duration of infection in mice intravaginally challenged with Chlamydia muridarum. These data demonstrate the potential for CDA as a mucosal adjuvant for vaccines against Chlamydia genital tract infection., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Daisy Arroyo reports financial support was provided by Vaxcyte, Inc. Tony Bruno reports financial support was provided by Vaxcyte, Inc. Manhong Wu reports financial support was provided by Vaxcyte, Inc. James Rozzelle reports financial support was provided by Vaxcyte, Inc. Jeff Fairman reports financial support was provided by Vaxcyte, Inc. Taylor B. Poston has patent Chlamydial Protease-Like Activity Factor and Adjuvant Compositions And Uses Thereof pending to Assignee. Toni Darville has patent Chlamydial Protease-Like Activity Factor and Adjuvant Compositions And Uses Thereof pending to Assignee. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

To estimate the relative effectiveness of NVX-CoV2373 versus BNT162b2 (Pfizer-BioNTech) in preventing SARS-CoV-2 infection and severe COVID-19 disease during the Omicron variant dominance in South Korea, we conducted a retrospective cohort-study among ≥12-year-olds using the K-COV-N database, which links COVID-19 vaccine registry data with health insurance claims data. The Cox proportional-hazards model and inverse probability of treatment weighting were employed to calculate adjusted hazard ratios (aHRs). Among homologous primary-series NVX-CoV2373 versus BNT162b2 recipients at Day 180 post-vaccination, the aHR was 0.90 (95% CI: 0.87-0.93) for all laboratory-confirmed and 0.65 (95% CI: 0.48-0.88) for severe infections. Among homologous 1st-booster recipients, it was 1.15 (95% CI: 1.01-1.30) for all laboratory-confirmed and 0.39 (95% CI: 0.20-0.75) for severe infections. At 180-days post-immunization, we observed homologous, NVX-CoV2373 primary-series added and 1st booster offered comparable protection against SARS-CoV-2 infection versus BNT162b2., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Eunseon Gwak, Erdenetuya Bolormaa, Young June Choe, and Seung-Ah Choe are investigators of the study and do not have any conflicts to report. Jonathan Fix, Matthew Dr. Rousculp, and Muruga Vadivale are all employees of Novavax, Inc. and may hold stock in Novavax, Inc. Chengbin Wang used to be employed by Novavax, Inc. and holds stock in Novavax. Inc., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Maternal mental illness (MMI) affects almost a quarter of mothers and may impact a child's development and physical health. It remains unclear whether MMI is associated with altered utilization of vaccination services. Understanding this association could help to identify families in need of additional support., Methods: Using primary care data from England, we conducted a historical cohort study of 397,519 children born in England between 2006 and 2014 with linked maternal records. Associations between different types of MMI (common mental disorders, severe mental illness and alcohol and substance use disorder) with childhood immunisation were explored using logistic regression for differences in coverage and accelerated failure time models for differences in timeliness before the child's fifth birthday., Results: While there were no differences in vaccination coverage at the age of one, children of mothers with common mental disorders had lower odds of being vaccinated at the ages of two (OR 0.95, 95 %CI: 0.93-0.98) and five (OR 0.86, 95 % CI 0.84-0.89) in comparison to children of mothers with no record of MMI. Vaccination coverage was even lower for children of mothers with comorbid substance disorder and common mental disorder (OR 0.70, 95 % CI: 0.62-0.78 at the age of five). There were no significant differences in timeliness of vaccine receipt by MMI., Conclusions: Inequalities in vaccination coverage associated with MMI grow with increasing age of the child. Extending support services for women with MMI beyond the child's first year of life could offer potential to improve vaccination uptake and reduce childhood infections., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The COVID-19 pandemic underscored the issue of vaccine hesitancy, leading researchers to study the determinants of people's willingness to receive the COVID-19 vaccine. This study is the first to comprehensively investigate the role of preventive practices at both the individual and contextual level, drawing on the theoretical concept of "cultural health capital"., Methods: Utilizing data from the Survey of Health, Ageing, and Retirement (SHARE), covering information from 18,454 individuals aged 50 years and above residing in 25 European countries, we examined the influence of past engagement in preventive practices and the prevalence of such practices within a country on the likelihood of COVID-19 vaccine uptake. Our analysis included (i) previous vaccination behaviors, (ii) other healthcare-related behaviors, and (iii) lifestyle factors at both the individual and contextual levels. Leveraging the longitudinal design of the SHARE, we accounted for the temporal ordering of the relationships., Results: At the individual level, almost all preventive behaviors were significantly related to people's willingness to receive the COVID-19 vaccine. Individuals who (i) had received an influenza vaccination prior to the COVID-19 outbreak and during childhood, (ii) had regularly participated in dental and blood pressure check-ups throughout their lives, and (iii) did not engage in lifestyle-related risk behaviors, were more likely to accept the COVID-19 vaccine. Notably, alcohol use was not significantly associated. At the contextual level, only the vaccination coverage rate for influenza was found to be robustly related, indicating that individuals were more inclined to receive the COVID-19 vaccine in countries with higher influenza vaccination rates prior to the pandemic., Conclusion: Active participation in preventive practices and effective implementation of vaccination campaigns can contribute to the development of (institutional) cultural health capital, which ultimately promotes a greater willingness to get vaccinated against COVID-19., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Katrijn Delaruelle reports financial support was provided by EU Framework Programme for Research and Innovation Societal Challenges. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)