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The goal of this study was to investigate the serological titers of circulating antibodies against human papillomavirus (HPV) type 16 (anti-HPV16) prior to the detection of an incident HPV16 or HPV31 infection amongst vaccinated participants. Patients were selected from a prospective post-HPV vaccine longitudinal cohort at Mount Sinai Adolescent Health Center in Manhattan, NY. We performed a nested case-control study of 43 cases with incident detection of cervical HPV16 ( n = 26) or HPV31 ( n = 17) DNA who had completed the full set of immunizations of the quadrivalent HPV vaccine (4vHPV). Two control individuals whom had received three doses of the vaccine (HPV16/31-negative) were selected per case, matched on age at the first dose of vaccination and follow-up time in the study: a random control, and a high-risk control that was in the upper quartile of a sexual risk behavior score. We conducted an enzyme-linked immunosorbent assay (ELISA) for the detection of immunoglobulin G (IgG) antibodies specific to anti-HPV16 virus-like particles (VLPs). The results suggest that the average log antibody titers were higher among high-risk controls than the HPV16/31 incident cases and the randomly selected controls. We show a prospective association between anti-HPV16 VLP titers and the acquisition of an HPV16/31 incident infection post-receiving three doses of 4vHPV vaccine.

Background: In Luxembourg, the human papillomavirus (HPV) vaccination program introduced in 2008, provided either bivalent (BV) or quadrivalent (QV) vaccines to girls aged 12-17 years. Here, we estimate the effectiveness of BV and QV vaccines combined and separately in reducing type-specific HPV prevalence eight years after the introduction of the vaccination program., Methods: A cross-sectional prevalence study was conducted among women aged 18-29 years in 2015-2017. Seven hundred sixteen participants were recruited at family planning centres or private gynaecology practices in Luxembourg. Vaccination records were verified in the social security database. Cervical samples were tested using the Anyplex II HPV28 assay. Vaccine effectiveness was estimated using logistic regression., Results: In total, 363/716 (50.7%) participants were HPV positive with any HPV and 209/716 (29.2%) with carcinogenic HPV genotypes. HPV vaccination offered high protection against HPV16/18 (adjusted odds ratio (AOR) = 0.13; 95% CI 0.03-0.63), HPV6/11 (AOR = 0.16; 95% CI 0.05-0.48) and cross-protection against HPV31/33/45 (AOR = 0.41; 95% CI 0.18-0.94). The AORs were generally enhanced when only considering vaccination before sexual debut corresponding to AORs: 0.05 (95% CI 0.00-0.88), 0.08 (95% CI 0.02-0.36) and 0.20 (0.06-0.65) against HPV16/18, HPV6/11 and HPV31/33/45, respectively. We observed significant protection against carcinogenic genotypes included in nonavalent vaccine for BV (AOR = 0.29; 95% CI 0.13-0.67), but not for QV (AOR = 0.81; 95% CI 0.47-1.40) (heterogeneity Chi 2 P = 0.04)., Conclusions: Our study suggests high effectiveness of HPV vaccination against HPV6/11, HPV16/18 and a cross-protection against HPV31/33/45. Vaccination effectiveness was slightly higher for women vaccinated before sexual debut., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

This study for the first time assessed quadrivalent human papillomavirus (qHPV) vaccine effectiveness against HPV6/11/16/18-related high-grade cervical disease in Japanese women (16-26 years old), as previously demonstrated in overseas trials, and vaccine safety in a longer term (48-month) open-label study (NCT01544478). Participants received three doses of qHPV vaccine (Day 1, Month 2, Month 6). Effectiveness endpoints, assessed in the per-protocol population, included incidence of HPV6/11/16/18-related cervical intraepithelial neoplasia (CIN) Grade 2 or worse (CIN Grade 2 and 3, adenocarcinoma in situ, and/or cervical cancer) as primary endpoint and incidence of external genital lesions (EGLs). Disease related to other high-risk HPV types was also assessed. Adverse events (AEs) and serious AEs (SAEs) were collected from Days 1-15 after any vaccination; vaccine-related SAEs, deaths, and new medical conditions were collected throughout the study. A total of 1030 women received at least one vaccination. No cases of CIN2 or worse or EGLs were reported in the per-protocol population. Injection site-related AEs were reported in 14.5% of participants; most were mild and resolved within 15 days. Vaccine-related systemic AEs occurred in 8.6% of participants, most commonly headache (2.3%), malaise (1.7%), and pyrexia (1.3%). There were no vaccine-related SAEs; one participant discontinued due to a vaccine-related AE of mild uticaria. Overall, qHPV vaccine effectiveness against HPV6/11/16/18-related high-grade cervical disease and EGLs was indicated in Japanese women. The vaccine was well-tolerated, without new safety signals throughout the 48-month study period. Findings are consistent with overseas qHPV vaccine pivotal trials. CLINICAL TRIAL REGISTRY: clinicaltrials.gov; NCT01544478., (Copyright © 2019 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Extending two-dose recommendations of HPV vaccine to girls between 15 and 18 years will reduce program cost and improve compliance. Immunogenicity and vaccine targeted HPV infection outcomes were compared between 1795 girls aged 15-18 years receiving two (1-180 days) and 1515 girls of same age receiving three (1-60-180 days) doses. Immunogenicity outcomes in 15-18 year old two-dose recipients were also compared with the 10-14 year old three-dose (N = 2833) and two-dose (N = 3184) recipients. The 15-18 year old two-dose recipients had non-inferior L1-binding antibody titres at seven months against vaccine-targeted HPV types compared to three-dose recipients at 15-18 years and three-dose recipients at 10-14 years of age. Neutralizing antibody titres at 18 months in 15-18 year old two-dose recipients were non-inferior to same age three-dose recipients for all except HPV 18. The titres were inferior to those in the 10-14 year old three-dose recipients for all targeted types. Frequency of incident infections from vaccine-targeted HPV types in the 15-18 year old two-dose recipients was similar to the three dose recipients. None of the girls receiving two or three doses had persistent infection from vaccine-targeted types. These findings support that two doses of HPV vaccine can be extended to girls aged 15-18 years., (Copyright © 2018. Published by Elsevier B.V.)

Influenza is a highly contagious viral infection and poses a serious burden, especially for children under 5 years of age due to an increased risk of severe illness and hospitalization. Influenza-related infant mortality during the pre-Covid period was reported annually. The highest mortality rate was regularly recorded among young children and especially children under the age of 6 months. Influenza vaccination in young children has been proven to be safe and effective. Influenza vaccination of young children not only protects this vulnerable age group, but is also an important way to reduce the transmission of influenza to others at risk, as well as reduce the use of healthcare services, including the use of antibiotics. Immunization against influenza in the current epidemiological conditions is especially relevant, since during the ongoing COVID-19 pandemic, it is impossible to predict the intensity and timing of the upcoming influenza seasonal rise. To prevent influenza in children, any licensed influenza vaccine that meets the indications is used, however, in modern conditions, the priority in influenza prevention is the use of quadrivalent vaccines that ensure the development of the most stable immune response against key strains of influenza viruses. Quadrivalent influenza vaccines include two influenza B strains of the Yamagata and Victoria B lines in addition to influenza A strains (H1N1 and H3N2). Studies have shown that immunization with the quadrivalent vaccine, including in young children, is well tolerated and effectively protects against any circulating and antigenically matched strains of influenza viruses. Russian-made quadrivalent inactivated full-cycle influenza vaccine for the prevention of seasonal influenza is the first quadrivaccine in the Russian Federation approved for use in influenza immunization of children from 6 months of age and pregnant women. The vaccine complies with all World Health Organization recommendations on the composition and amount of hemagglutinin of an influenza virus strain – it contains 15 μg of influenza virus hemagglutinin of each strain (А(N1N1), A(N3N2), B line Yamagata, B line Victoria); does not contain immunomodulators, adjuvants and preservatives; meets the immunogenicity criteria for inactivated influenza vaccines adopted in the European Union and the Russian Federation.

Standard-dose quadrivalent influenza vaccines (QIV) are designed to provide protection against all four influenza strains. Adjuvanted QIV (aQIV), indicated for individuals aged 65+ years, combines MF59® adjuvant (an oil-in-water emulsion of squalene oil) with a standard dose of antigen, and is designed to produce stronger and longer immune response, especially in the elderly where immunosenescence reduces vaccine effectiveness. This study evaluated the cost-effectiveness of aQIV vs. egg-based standard-dose QIV (QIVe) in the elderly population, from the payer and societal perspective in Spain. A dynamic transmission model, which accounts for herd protection, was used to predict the number of medically attended infections in Spain. A decision tree structure was used to forecast influenza-related costs and benefits. Influenza-related probabilities of outpatient visit, hospitalization, work absenteeism, mortality, and associated utilities and costs were extracted from Spanish and European published literature. Relative vaccine effectiveness (rVE) was sourced from two different meta-analyses: the first meta-analysis was informed by laboratory-confirmed influenza studies only, resulting in a rVE = 34.6% (CI95% 2–66%) in favor of aQIV; the second meta-analysis included real world evidence influenza-related medical encounters outcomes, resulting in a rVE = 13.9% (CI95% 4.2–23.5%) in benefit of aQIV. All costs were expressed in 2021 euros. Results indicate that replacing QIVe with aQIV in the Spanish elderly population would prevent on average 43,664 influenza complicated cases, 1111 hospitalizations, and 569 deaths (with a rVE = 34.6%) or 19,104 influenza complicated cases, 486 hospitalizations, and 252 deaths (with a rVE = 13.9%). When the rVE of aQIV vs. QIVe is 34.6%, the incremental cost per quality adjusted life years (QALY) gained was €2240 from the payer; from the societal perspective, aQIV was cost saving compared with QIVe. If the rVE was 13.9%, the incremental cost per QALY was €6694 and €3936 from the payer and societal perspective, respectively. Sensitivity analyses validated the robustness of these findings. Results indicate that replacing QIVe with aQIV in the Spanish elderly population is a cost-effective strategy for the Spanish healthcare system. [ABSTRACT FROM AUTHOR]

Neuromyotonia is a rare peripheral nerve hyperexcitability syndrome often associated with antibodies directed against contactin-associated protein-like 2 and leucine-rich, glioma inactivated 1. The quadrivalent human papilloma virus vaccine Gardasil®, first approved in 2006, is known to be a highly effective prophylaxis against papillomavirus types 6, 11, 16, and 18. Molecularly, this non-infectious recombinant vaccine is based on purified L1 proteins from the human papilloma virus capsid. Since the approval of this vaccine, several studies have investigated its safety regarding the occurrence of autoimmune conditions following application. Here, we present the first case of neuromyotonia with active Gadolinium enhancing demyelinating central nervous system lesions following vaccination with Gardasil®. [ABSTRACT FROM AUTHOR]

A fully government-funded human papillomavirus (HPV) vaccination program started in 2007 in Spain (only 11–14-year-old girls). The first of those vaccinated cohorts, with the quadrivalent vaccine (Gardasil), turned 25 years old in 2018, the age at which cervical cancer screening begins in Spain. The current study could provide the first evidence about the effectiveness of the quadrivalent vaccine against HPV in Spain and the influence of age of vaccination. The present ambispective cohort study, which was conducted on 790 women aged 25 and 26 years old, compares the rate of HPV prevalence and cytologic anomaly according to the vaccination status. The overall infection rate was 40.09% (vaccinated group) vs. 40.6% (non-vaccinated group). There was a significant reduction in the prevalence of HPV 6 (0% vs. 1.3%) and 16 (2.4% vs. 6.1%), and in the prevalence of cytological abnormalities linked to HPV16: Atypical Squamous Cells of Undetermined Significance (ASCUS) (2.04% vs. 14%), Low-grade Squamous Intraepithelial Lesions (LSIL) (2.94% vs. 18.7%) and High-grade Squamous Intraepithelial Lesion (HSIL) (0% vs. 40%), in the vaccinated group vs. the non-vaccinated group. Only one case of HPV11 and two cases of HPV18 were detected. The vaccine effectively reduces the prevalence of vaccine genotypes and cytological anomalies linked to these genotypes. [ABSTRACT FROM AUTHOR]

According to requirements of WHO, the trivalent influenza vaccines (TIV) have to contain antigens of two influenza A strains (A/H1N1, A/H3N2) and one influenza B strain which can be presented by antigens of a virus of lineages Yamagata or Victoria. In a season of 2017/2018 the discrepancy of the vaccinal and circulating influenza B strains was noted that caused decrease in effectiveness of vaccination, especially at children’s age when the frequency of detection of influenza B is higher, than in other age groups. Now in the Russian Federation it is registered, in addition to TIV, quadrivalent vaccine (QIV) manufactured in the Russian Federation and including antigens of influenza B viruses of the two lineages.The purpose of work was assessment of the cost-effectiveness of QIV in comparison with TIV at children of preschool age on the basis of epidemiological data on the Russian Federation for a season of 2017/2018.Material and methods. The analysis was carried out by a modeling method from a health care system and societal perspective taking into account epidemiological data on the Russian Federation and the European data on effectiveness of TIV at citizens of various age. Indirect effect of vaccination was not considered. The cost of the TIV and QIV (Grippol plus and Grippol quadrivalent, respectively) corresponded to the registered price including VAT.Results. The analysis showed that use QIV instead of TIV for children of preschool age in an epidemiological season of 2017/2018 would allow to increase quantity of the prevented influenza cases by 17.1%. The prevented indirect costs exceed the prevented direct medical costs. The incremental cost-effectiveness ratio (ICER) is 1042.65-1093.7 thousand rubles/QALY in the analysis from the health care system perspective and 124.50-267.91 thousand rubles/QALY in the analysis from the societal perspective.Conclusions. Vaccination against influenza of children of preschool age in the Russian Federation in a season of 2017/2018 with quadrivalent vaccine would allow to increase significantly the number of the prevented cases of disease and could be considered as economically highly effective intervention. Reduction of vaccine price less, than for 5% in comparison with the registered price would allow to avoid completely additional budget burden.

Standard-dose quadrivalent influenza vaccines (QIV) are designed to provide protection against all four influenza strains. Adjuvanted QIV (aQIV), indicated for individuals aged 65+ years, combines MF59® adjuvant (an oil-in-water emulsion of squalene oil) with a standard dose of antigen, and is designed to produce stronger and longer immune response, especially in the elderly where immunosenescence reduces vaccine effectiveness. This study evaluated the cost-effectiveness of aQIV vs. egg-based standard-dose QIV (QIVe) in the elderly population, from the payer and societal perspective in Spain. A dynamic transmission model, which accounts for herd protection, was used to predict the number of medically attended infections in Spain. A decision tree structure was used to forecast influenza-related costs and benefits. Influenza-related probabilities of outpatient visit, hospitalization, work absenteeism, mortality, and associated utilities and costs were extracted from Spanish and European published literature. Relative vaccine effectiveness (rVE) was sourced from two different meta-analyses: the first meta-analysis was informed by laboratory-confirmed influenza studies only, resulting in a rVE = 34.6% (CI95% 2–66%) in favor of aQIV; the second meta-analysis included real world evidence influenza-related medical encounters outcomes, resulting in a rVE = 13.9% (CI95% 4.2–23.5%) in benefit of aQIV. All costs were expressed in 2021 euros. Results indicate that replacing QIVe with aQIV in the Spanish elderly population would prevent on average 43,664 influenza complicated cases, 1111 hospitalizations, and 569 deaths (with a rVE = 34.6%) or 19,104 influenza complicated cases, 486 hospitalizations, and 252 deaths (with a rVE = 13.9%). When the rVE of aQIV vs. QIVe is 34.6%, the incremental cost per quality adjusted life years (QALY) gained was €2240 from the payer; from the societal perspective, aQIV was cost saving compared with QIVe. If the rVE was 13.9%, the incremental cost per QALY was €6694 and €3936 from the payer and societal perspective, respectively. Sensitivity analyses validated the robustness of these findings. Results indicate that replacing QIVe with aQIV in the Spanish elderly population is a cost-effective strategy for the Spanish healthcare system.

Human papilloma virus (HPV) infection is a major challenge to modern health care. At the moment there is only one way to effectively prevent diseases associated with HPV. There is vaccination. The available vaccines prevent most cases of HPVassociated diseases and can significantly reduce the financial burden of this infection. The article evaluated the economic and demographic burden of HPV-associated diseases in the Russian Federation, and also identifies the possible reduction of this burden with timely vaccination of girls by quadrivalent vaccine.

High prevalence of sexually transmitted diseases among the population attracts attention of specialists in all countries due to frequent development of complications resulting in reproductive dysfunction. The article presents one of the urgent issues of modern medicine — papillomavirus infection, which is the most common sexually transmitted disease. 70–80% of the sexually active persons contract human papilloma virus at one point. HPV induces a broad range of oncological reproductive diseases, including cervical, vulvar, vaginal and anal cancer and anogenital condylomae, which are observed both in men and women. The only reliable method of preventing papillomavirus infection is vaccination. The authors present new data on the use of the quadrivalent vaccine, including a new immunization pattern for 9–14-years-old girls.

The development of an effective preventative hepatitis C virus (HCV) vaccine will reside, in part, in its ability to elicit neutralizing antibodies (NAbs). We previously reported a genotype 1a HCV virus like particle (VLP) vaccine that produced HCV specific NAb and T cell responses that were substantially enhanced by Toll-like receptor 2 (TLR2) agonists. We have now produced a quadrivalent genotype 1a/1b/2a/3a HCV VLP vaccine and tested the ability of two TLR2 agonists, R4Pam2Cys and E8Pam2Cys, to stimulate the production of NAb. We now show that our vaccine with R4Pam2Cys or E8Pam2Cys produces strong antibody and NAb responses in vaccinated mice after just two doses. Total antibody titers were higher in mice inoculated with vaccine plus E8Pam2Cys compared to HCV VLPs alone. However, the TLR2 agonists did not result in stronger NAb responses compared to vaccine without adjuvant. Such a vaccine could provide a substantial addition to the overall goal to eliminate HCV. [ABSTRACT FROM AUTHOR]

Objective: The goal of this study was to review the current human papillomavirus (HPV) vaccine program and its outcomes to date in Australia. Methods: This was a review of the published data relating to the introduction and subsequent measurable outcomes of the quadrivalent vaccine, which became part of the Australian national HPV immunization program in 2007. Australia commenced an ongoing, schoolbased, government-funded, HPV vaccination program using the quadrivalent vaccine from April 2007 for adolescent female subjects aged 12 to 13 years, together with a catch-up program for female subjects 13 to 26 years of age from July 2007 to December 31, 2009. Results: The Australian community (lay and clinical) have embraced the program, resulting in high coverage with >70% for 3 doses in the 12- to 13-year-old ongoing target population. Vaccine effectiveness (outcomes of vaccination in a real-world setting) is already being seen. This effectiveness has been noted in significant reductions in HPV vaccine-related infections in vaccine eligible age female subjects (77% fall in prevalence), rapid reduction of >90% in genital warts (first marker of disease reduction, as well as herd immunity), and reduction in high-grade cervical lesions in this age group. These remarkable changes so soon after implementation of the vaccine in the country occurred faster, and to a greater extent, than anyone could have predicted. Conclusions: These findings from Australia should encourage other countries to follow suit, with the ultimate aim of translating treatment into reductions in HPV-related neoplasia globally. The greatest success from such an approach will only be realized when prophylactic vaccines are rolled out effectively, with high coverage and at affordable costs, to those areas of the world with the highest burden of disease. To achieve this outcome requires government endorsement and commitment; education of the community at large; realization of the safety, efficacy, and immunogenicity of the available prophylactic vaccines in reducing HPV-related infections and disease, especially neoplasia; and governments procuring vaccines at affordable prices through the various options now available (eg, support from the GAVI Alliance to eligible countries, tiered pricing, negotiation with pharmaceutical manufacturers). We have the tools to reach this goal, and it is time these tools were implemented. [ABSTRACT FROM AUTHOR]

Human papillomavirus (HPV) is an extremely prevalent sexually transmitted infection that is typically acquired soon after onset of sexual activity. The burden of HPV-related malignant and nonmalignant disease is high in men and women. High-risk or oncogenic types of HPV cause cervical, vaginal, and vulvar cancer in women. These types have also been shown to cause penile cancer in men and a substantial proportion of oropharyngeal and anal malignancy in men and women. Low-risk types of HPV cause anogenital warts. Prevention of penile, anal, and oropharyngeal cancers and anogenital warts represents potential benefits of the HPV vaccine in men. This review focuses on HPV disease in men, existing data on HPV vaccination in men, and various factors associated with the decision to vaccinate boys and young men, as well as the timing of vaccination. [ABSTRACT FROM AUTHOR]

Abstract: Meningococcal disease incidence is highest in infants, but a significant burden of disease also occurs in children. In this Phase II, single-centre US study, 619 healthy children (2–10 years of age) received one dose of an investigational quadrivalent meningococcal CRM197-conjugated vaccine (MenACWY-CRM) or a licensed quadrivalent meningococcal polysaccharide vaccine (MPSV4). Immunogenicity was assessed using the serum bactericidal assay with human complement (hSBA) at 1 and 12 months post-vaccination. Local and systemic reactions were recorded for 7 days, all adverse events (AEs) for 1 month, and medically significant and serious AEs (SAEs) for 12 months post-vaccination. For all four serogroups, more MenACWY-CRM recipients achieved an hSBA titre ≥1:4 at 1 month post-vaccination (A: 82%; C: 83%; W-135: 95%; Y: 91%) compared with the group that received MPSV4 (A: 45%; C: 66%; W-135: 71%; Y: 61%); this difference persisted through to 12 months post-vaccination. Both vaccines were well tolerated. In children 2–10 years of age, MenACWY-CRM induced a higher immune response than that of MPSV4, and was well tolerated. [Copyright &y& Elsevier]

Globally, cervical cancer is second only to breast cancer as the leading cause of cancer in women, with a global prevalence of 2.3 million. It is the third most common cause of female cancer-related mortality worldwide, and 82% of new cervical cancer cases occur in developing countries. As stated by WHO, “without screening programs, cervical cancer is detected too late and leads to death in almost all cases.” However, even in Europe, the United States, and Canada, where most women have access to routine screening, approximately 30,000 women die each year. Infection with oncogenic types of HPV 16 and 18 is the most significant risk/causative factor in cervical cancer etiology, and worldwide HPV positivity in cervical carcinoma has been documented to be 99.7%. In 2006 Merck's quadrivalent vaccine was approved by FDA. It targets four HPV types (6, 11, 16, and 18) that are involved in cervical cancer, high and low grade squamous intraepithelial lesions, and anogenital warts. Results from combined Phase II/III studies show that the efficacy of vaccine was 95–100% against LGSIL and HGSIL related to HPV 16 and 18 and vaccine use led to a 99% reduction in the incidence of genital warts (related to HPV 6 and 11). Due to morbidity associated with infection with HPV types 6, 11, 16, and 18, a prophylactic quadrivalent HPV vaccine targeting these four HPV types is expected to substantially reduce the burden of HPV-related disease. [ABSTRACT FROM AUTHOR]

Summary: Background: Varicella is often considered to be a benign disease of childhood. In fact, varicella is associated with serious complications and mortality even among healthy individuals. Discussion: Although the course of varicella can be uncomplicated, it can also be associated with serious complications such as pneumonia, fluid and electrolyte disturbances, skin and soft tissue infections and central nervous system disturbances. Worldwide studies have confirmed the high frequency of disease as well as the resultant morbidity, mortality and medical resource use. A quadrivalent vaccine is now available in certain countries to protect against measles, mumps, rubella and varicella (MMRV). Countries that have initiated routine vaccination pro- grams have reported substantial reductions in morbidity and mortality as well as improved health outcomes. The MMRV vaccine facilitates coverage against all four diseases, and would be expected to improve compliance as well as coverage of varicella. Conclusions: Universal vaccination programs with MMRV should be considered as a way to reduce the medical and economic impact of varicella. The MMRV vaccine provides a means to achieve universal coverage. [Copyright &y& Elsevier]