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Background: Recombinant protein-based vaccines targeting serogroup B meningococci protect against invasive disease but impacts on carriage are uncertain. This study assessed carriage prevalence of disease-associated meningococci in 2018-2020 as the proportion of vaccinated adolescents increased following introduction of a school-based 4CMenB immunization program.Methods: Eligible participants who completed high school (aged 17-25) in South Australia in the previous year had an oropharyngeal swab taken and completed a risk factor questionnaire. Disease-associated meningococci (genogroups A, B, C, W, X, Y) were detected by meningococcal and genogroup-specific polymerase chain reaction.Results: The analysis included 4104 participants in 2018, 2690 in 2019, and 1338 in 2020. The proportion vaccinated with 4CMenB increased from 43% in 2018, to 78% in 2019, and 76% in 2020. Carriage prevalence of disease-associated meningococci in 2018 was 225/4104 (5.5%). There was little difference between carriage prevalence in 2019 (134/2690, 5.0%; adjusted odds ratio [aOR], 0.82; 95% confidence interval [CI], .64-1.05) and 2020 (68/1338, 5.1%; aOR, 0.82; 95% CI, .57-1.17) compared to 2018.Conclusions: Increased 4CMenB uptake in adolescents was not associated with decline in carriage of disease-associated meningococci. 4CMenB immunization programs should focus on direct (individual) protection for groups at greatest risk of disease.Clinical Trials Registration: NCT03419533. [ABSTRACT FROM AUTHOR]

Background Higher density of Neisseria meningitidis carriage may be associated with transmission of the meningococcus. Our aim was to establish the impact of meningococcal B (4CMenB) vaccine on N. meningitidis carriage density. Methods We compared 4CMenB vaccine to control among 913 South Australian students aged approximately 15–18 years in a cluster randomized trial who had N. meningitidis carriage at 12 months. Oropharyngeal swabs were collected at baseline and 12 months later to detect N. meningitidis carriage. Colony-forming units per milliliter (CFU/mL) were estimated by generating a standard curve that plotted quantitative polymerase chain reaction cycle threshold values against log-normalized CFU. Results Among the 913 students with N. meningitidis carriage at 12 months, there was no difference in mean carriage density between the vaccinated (n = 434; 3.80 log CFU/mL [standard deviation {SD}, 1.29]) and control group (n = 479; 3.73 log CFU/mL [SD, 1.30]; P  = .51). Higher N. meningitidis carriage density at baseline was associated with an increase in the odds of persistent carriage at 12 months (n = 504; odds ratio [OR] per 1.0 log CFU/mL increase in density, 1.36 [95% confidence interval {CI}, 1.17–1.58]; P  < .001). Students with baseline carriage who were vaccinated had decreased persistent N. meningitidis carriage at 12 months compared to unvaccinated students (81/260 [31%] vs 105/244 [43%]; OR, 0.60 [95% CI,.40–.90]; P  = .01). Conclusions 4CMenB vaccine did not reduce carriage density of N. meningitidis 12 months postvaccination, despite increased carriage clearance. Higher carriage density is likely to enable transmission through prolonged periods of population exposure. Clinical Trials Registration NCT03089086. [ABSTRACT FROM AUTHOR]

Background From 2017, a statewide cluster randomized trial was conducted in South Australia to assess the impact of the meningococcal B vaccine 4CMenB on pharyngeal Neisseria meningitidis carriage in adolescents. Senior schools were randomized to receive the vaccine in 2017 (intervention) or 2018 (control). In this study we report the vaccine impact of 4CMenB on serogroup B invasive meningococcal disease (IMD) in 16- to 19-year-old adolescents in South Australia. Methods This observational time series analysis of serogroup B IMD cases compares the 14 years prior to the commencement of the trial (2003–2016) with the 2 years following 4CMenB vaccination of the 2017 adolescent cohort. Results Approximately 62% of year 10 and 11 students (15–16 years old) in South Australia enrolled in the trial. A total of 30 522 year 10–12 students received at least 1 dose of 4CMenB. The number of serogroup B IMD cases in 16- to 19-year old adolescents in South Australia increased on average by 10% per year from 2003 to 2016 (95% confidence interval [CI], 6%–15%, P  < .001), peaking with 10 cases in 2015. Serogroup B IMD cases reduced to 5 in 2017–2018 and 1 in 2018–2019, below the expected numbers of 9.9 (95% prediction interval [PI], 3.9–17.5) and 10.9 (95% PI, 4.4–19.1), respectively. This translated to an overall reduction in the number of serogroup B IMD cases of 71% (95% CI, 15%–90%, P  = .02). There were no serogroup B IMD cases in vaccinated adolescents. Conclusions Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia. Clinical Trials Registration NCT03089086. [ABSTRACT FROM AUTHOR]

• 58,637 doses of 4CMenB vaccine were administered to 30,522 students. • 193 AEFI including nine serious adverse events in 187 students were reported. • The AEFI reporting rate was low and consistent with other adolescent vaccines. Four-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease. To assess the safety profile of two doses of 4CMenB in adolescents. Cluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI. 58,637 doses of 4CMenB vaccine were administered to 30,522 students (median age 16 years) during 2017–2018. Of 18,348 and 12,174 students vaccinated in 2017 and 2018, 97.3% and 84.3%, respectively, received both scheduled doses (N = 28,115). 193 AEFI in 187 students were reported with a reporting rate of 0.32% (95%CI: 0.28–0.39%). Seventy individuals sought medical review, including nine serious adverse events. 98% (166/169) of those who were contactable for AEFI follow-up (87.6% 169/193) reported resolution of the event. Most common AEFI were injection site reaction (126/193), headache (99/193) and nausea (61/193). AEFI were more frequently reported in females (aOR = 1.409 (95%CI: 1.002, 1.980)), schools with high level of educational advantage (adjusted Odds Ratio (aOR) = 1.515 (95%CI: 1.005, 2.284)), following first dose (aOR = 1.619 (95%CI: 1.168, 2.244)), and in 2017 (aOR = 1.437 (95%CI: 1.001, 2.064)). Reported AEFI declined with increasing age (aOR = 0.771 (95%CI: 0.673, 0.883)). In this largest post-licensure use of 4CMenB in adolescents, the low AEFI reporting rate provides real-world evidence of 4CMenB safety in this age group. (ClinicalTrials.gov number: NCT03089086). [ABSTRACT FROM AUTHOR]

Background: Maternal immunization is an effective strategy to protect pregnant women and their infants from vaccine-preventable diseases. Despite the recommendation of maternal influenza and more recently pertussis immunization in Australia, uptake of these vaccines has been suboptimal. A midwife delivered immunization program for pregnant women at the Women’s and Children’s Hospital in South Australia commenced in April 2015. Monitoring the uptake of the current funded vaccine programs for pregnant women is limited. The study aimed to estimate maternal vaccine uptake and assess factors associated with influenza and pertussis vaccine uptake among pregnant women. Methods: This prospective study was undertaken between November 2014 and July 2016 at the Women’s and Children’s Hospital. Following consent, demographic details and vaccination history for South Australian pregnant women who attended the antenatal clinic were collected. A standardised self-reported survey was completed during pregnancy with a follow up telephone interview at 8–10 weeks post-delivery. Results: 205 women consented and completed the self-reported survey. Of the 180 pregnant women who completed the study, 76% and 81% received maternal influenza and pertussis vaccines respectively. The adjusted odds of women receiving maternal vaccines during pregnancy were significantly higher for women delivering after the implementation of the midwife delivered program compared with women who delivered babies prior to the program for both pertussis vaccination (AOR 21.17, 95% CI 6.14–72.95; p<0.001) and influenza vaccination (AOR 5.95, 95% CI 2.13–16.61, p<0.001). Women receiving a recommendation from a health care provider and first time mothers were significantly more likely to receive influenza vaccination during pregnancy. Conclusions: High uptake of influenza and pertussis vaccines during pregnancy can be attained with health care provider recommendation and inclusion of maternal immunization as part of standard antenatal care. A midwife delivered maternal immunization program is a promising approach to improve maternal vaccine uptake by pregnant women. [ABSTRACT FROM AUTHOR]

Background. High, or increasing, rates of invasive Haemophilus influenzae (Hi) type a disease have been reported from North American native children from circumpolar regions, raising the question of serotype replacement being driven by vaccination against Hi type b (Hib). Indigenous Australians from remote areas had high rates of invasive Hib disease in the past, comparable to those in North American Indigenous populations. Objective. Evaluate incidence rates of invasive Hi (overall and by serotype) in Indigenous Australian children over time. Design. Descriptive study of Hi incidence rates by serotype, in the Northern Territory (NT) and South Australia (SA) from 2001 to 2011. Comparison of NT data with a study that was conducted in the NT in 1985_1988, before Hib vaccine was introduced. Results. The average annual rate of invasive Hi type a (Hia) disease in Indigenous children aged B5 years was 11/100,000 population. Although the incidence of Hi infection in Indigenous children in 2001-2003 was lower than during 2004-2011, this may be due to changes in surveillance. No other trend over time in individual serotypes or total invasive Hi disease, in Indigenous or non-Indigenous people, was identified. Compared to 1985-1988, rates in 2001-2011 were lower in all serotype groupings, by 98% for Hib, 75% for Hia, 79% for other serotypes and 67% for non-typeable Hi. Conclusions. There is no evidence of increases in invasive disease due to Hia, other specific non-b types, or non-typeable Hi in Australian Indigenous children. These data suggest that the increase in Hia some time after the introduction of Hib vaccine, as seen in the North American Arctic Region, is not common to all populations with high pre-vaccine rates of invasive Hib disease. However, small case numbers and the lack of molecular subtyping and PCR confirmation of pre-vaccine results complicate comparisons with North American epidemiology. [ABSTRACT FROM AUTHOR]

Abstract: Background: Trends in age specific and serotype specific incidence rates for invasive pneumococcal disease (IPD) were examined in South Australia 4 years before and 5 years after the commencement of the Australian universal childhood 7 valent pneumococcal conjugate vaccine (7vPCV) program. Methods: IPD cases were identified by routine enhanced surveillance. IPD serotypes were grouped according to those covered by the 7vPCV, the six serotypes specific to the 13 valent pneumococcal conjugate vaccine (13vPCV), the 11 serotypes specific to the 23 valent pneumococcal polysaccharide vaccine (23vPPV), as well as non-13vPCV and non-23vPPV groups. Poisson regression was used to calculate age-specific and serotype-specific incident rate ratios (IRRs) comparing pre (2002–2004) and post (2007–2009) universal childhood 7vPCV periods. Results: Following the introduction of the 7vPCV program, the rate of IPD in children aged <2 years decreased by 81% for all serotypes (IRR 0.19, 95% CI, 0.13–0.28) and by 98% for 7vPCV serotypes (IRR 0.02, 95% CI, 0.007–0.07). At the same time, there was some evidence for an increase in IPD caused by 13vPCV specific serotypes (IRR 1.58, 95% CI, 0.78–3.21) and non-13vPCV serotypes (IRR 1.80, 95% CI, 0.45–7.21). Among adults aged ≥65 years, overall there was a 27% reduction in IPD caused by all serotypes following introduction of the 7vPCV program (IRR 0.73, 95% CI, 0.58–0.93). However, the rate of IPD increased in the last 2 years of the study period. The initial decrease was a result of a 74% reduction in the rate of IPD due to 7vPCV serotypes (IRR 0.26, 95% CI, 0.17–0.40). At the same time, the rate of IPD increased for 13vPCV specific serotypes (IRR 1.55, 95% CI, 0.94–2.54), 23vPPV specific serotypes (IRR 1.91, 95% CI, 0.99–3.71) and particularly non-23vPPV serotypes (IRR 5.3, 95% CI, 1.83–15.34). Conclusion: There has been a large direct and sustained benefit from the universal 7vPCV program in children, particularly those aged <2 years, with some evidence for serotype replacement. There is also good evidence that the childhood program has provided indirect benefits to adults aged ≥65 years, although serotype replacement has reduced the initial benefits. [Copyright &y& Elsevier]

Abstract: Molecular typing at the 18S rRNA and Gp60 loci was conducted on Cryptosporidium-positive stool samples from cases collected during 2007 Western Australian and South Australian outbreaks of cryptosporidiosis. Analysis of 48 Western Australian samples identified that all isolates were C. hominis and were from five different Gp60 C. hominis subtype families. The IbA10G2 subtype was most common across all age groups (37/48). In South Australia, analysis of 24 outbreak samples, identified 21 C. hominis isolates, two C. parvum isolates and one sample with both C. hominis and C. parvum. All C. hominis isolates were identified as the IbA10G2 subtype. [Copyright &y& Elsevier]

Introduction: Invasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria, Neisseria meningitidis , is high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess the impact of a meningococcal B (MenB) vaccine on meningococcal carriage was implemented in the state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017-2018. This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in SA, 1 and 2 years after implementation of the cluster RCT in adolescents. Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns., Methods and Analysis: This repeat cross-sectional study will assess carriage prevalence in 2018 and 2019. All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study. An oropharyngeal swab will be taken from each participating student and a risk factor questionnaire completed by the student following informed consent. Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics. Confirmed vaccination history will allow a comparison in carriage prevalence between vaccinated and unvaccinated school leavers. A sample size of 4096 students per year will provide 80% power to detect a 20% difference in carriage prevalence of disease-causing meningococci (defined as genogroup A, B, C, W, X or Y) between years., Ethics and Dissemination: The study was approved by the Women's and Children's Health Network Human Research Ethics Committee. Results will be published in international peer review journals and presented at national and international conferences., Trial Registration Number: NCT03419533; Pre-results., Competing Interests: Competing interests: HSM is supported by an NHMRC CDF APP1084951 and is a member of the Australian Technical Advisory Group on Immunisation, Australian Government. HSM is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). HSM’s and MMcM’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK). HSM and MMcM receive no personal payments from Industry. CT has received a consulting payment from GSK and an honorarium from Sanofi Pasteur. RB performs contract research on behalf of Public Health England for GSK, Pfizer and Sanofi Pasteur. PR is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). PR’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK, CSL). PR has been a member of scientific vaccine advisory boards for Industry (Pfizer, GSK, Sanofi) but has not received any personal payments from Industry. AF’s institution is in receipt of research funding from GlaxoSmithKline, Pfizer and consultancy fees from Alios BioPharma/Johnson & Johnson, BioNet-Asia and VBI Vaccines. AF is a member of the UK Department of Health’s Joint Committee on Vaccination, chair of the WHO European Technical Advisory Group of Experts and president of the European Society for Paediatric Infectious Diseases, which receives sponsorship for its annual meeting from vaccine manufacturers. KV and JW are employees of the GSK group of companies and hold shares in the GSK group of companies as part of their employee remuneration., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: South Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B. Neisseria meningitidis is carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage of N. meningitidis in adolescents., Methods and Analysis: This is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16-18 years of age) throughout SA, in metropolitan and rural/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence of N. meningitidis will be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causing N. meningitidis at 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI., Ethics and Dissemination: The study was approved by the Women's and Children's Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools., Trial Registration Number: ACTRN12617000079347. NCT03089086; Pre-results., Competing Interests: Competing interests: HSM is supported by a NHMRC CDF APP1084951 and is a member of the Australian Technical Advisory Group on Immunisation, Australian Government. HSM is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). HSM’s and MMcM’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK). HSM and MMcM receive no personal payments from Industry. CT has received a consulting payment from GSK and an honorarium from Sanofi Pasteur. RB performs contract research on behalf of Public Health England for GSK, Pfizer and Sanofi Pasteur. PR is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). PR’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK, CSL). PR has been a member of scientific vaccine advisory boards for Industry (Pfizer, GSK, Sanofi) but has not received any personal payments from Industry. AF’s institution is in receipt of research funding from GlaxoSmithKline, Pfizer and consultancy fees from Alios BioPharma/Johnson & Johnson, BioNet-Asia and VBI Vaccines. AF is a member of the UK Department of Health’s Joint Committee on Vaccination, Chair of the WHO European Technical Advisory Group of Experts and President of the European Society for Paediatric Infectious Diseases, which receives sponsorship for its annual meeting from vaccine manufacturers. KV and JW are employees of the GSK group of companies and hold shares in the GSK group of companies as part of their employee remuneration., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Changing trends in foodborne disease are influenced by many factors, including temperature. Globally and in Australia, warmer ambient temperatures are projected to rise if climate change continues. Salmonella spp. are a temperature-sensitive pathogen and rising temperature can have a substantial effect on disease burden affecting human health. We examined the relationship between temperature and Salmonella spp. and serotype notifications in Adelaide, Australia. Time-series Poisson regression models were fit to estimate the effect of temperature during warmer months on Salmonella spp. and serotype cases notified from 1990 to 2012. Long-term trends, seasonality, autocorrelation and lagged effects were included in the statistical models. Daily Salmonella spp. counts increased by 1·3% [incidence rate ratio (IRR) 1·013, 95% confidence interval (CI) 1·008-1·019] per 1 °C rise in temperature in the warm season with greater increases observed in specific serotype and phage-type cases ranging from 3·4% (IRR 1·034, 95% CI 1·008-1·061) to 4·4% (IRR 1·044, 95% CI 1·024-1·064). We observed increased cases of S. Typhimurium PT9 and S. Typhimurium PT108 notifications above a threshold of 39 °C. This study has identified the impact of warm season temperature on different Salmonella spp. strains and confirms higher temperature has a greater effect on phage-type notifications. The findings will contribute targeted information for public health policy interventions, including food safety programmes during warmer weather.

To assess the impact of Bordetella pertussis infections in South Australia during an epidemic and determine vulnerable populations, data from notification reports for pertussis cases occurring between July 2008 and December 2009 were reviewed to determine the distribution of disease according to specific risk factors and examine associations with hospitalizations. Although the majority (66%) of the 6230 notifications for pertussis occurred in adults aged >24 years, the highest notification and hospitalization rate occurred in infants aged <1 year. For these infants, factors associated with hospitalization included being aged <2 months [relative risk (RR) 2·3, 95% confidence interval (CI) 1·60-3·32], Indigenous ethnicity (RR 1·7, 95% CI 1·03-2·83) and receiving fewer than two doses of pertussis vaccine (RR 4·1, 95% CI 1·37-12·11). A combination of strategies aimed at improving direct protection for newborns, vaccination for the elderly, and reducing transmission from close contacts of infants are required for prevention of severe pertussis disease.