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Studies of meningococcal genetic population structure, including the potential associations between surface proteins variants and clonal complexes, are important to understand how new protein MenB vaccines might impact in specific scenarios. With the aim to analyze the diversity of Spanish invasive MenB strains, and genetic variability of the fHbp vaccine antigen, all MenB isolates received at National Reference Laboratory (NRL) from 2015 to 2018 were molecularly characterized. 108, 103, 87 and 112 invasive MenB strains isolated during 2015-2018, respectively, were received at NRL. The strains were whole genome sequenced, and porA, fetA, MLST and fHbp variability was analyzed. Potential impact on MenB vaccines coverage was also assessed. A total of 42, 38 and 3 different FHbp subfamily A, B and A/B hybrid peptides, respectively, were found. FHbp subfamily A peptides were harboured by most of the strains (65.9%), being the most prevalent peptide 45 which was associated with genosubtype 22,14 and cc213. FHbp subfamily B peptides were harboured by 32.4% of the strains, and 6 strains harbouring subfamily A/B hybrid peptides were also found. The 64.15% of the strains showed FHbp variants "exact-match" or "cross-reactive" to the FHbp variants included in rLP2086 vaccine according to hSBA assays in the rLP2086 clinical development, and 15.85% showed FHbp peptides defined as predictors of FHbp-coverage for 4CMenB vaccine by gMATS. Due to invasive meningococcal strains temporal variability (eg prevalence of the cc213 increased from 3.6% in 2007 to 33% in 2018) affecting to the presence and distribution of the vaccine antigens, continuous detailed meningococcal surveillance and monitoring of the vaccine antigens is needed to determine the degree and durability of coverage provided by these protein vaccine. ; This study was partially supported by grants PI16CIII/00023 (MPY-1349/16) and PI19CIII/00030 (MPY-507/19) from Instituto de Salud Carlos III, and by Pfizer S.L.U. through an institutional agreement with the Instituto de Salud Carlos III (MVP-1273/16). This publication made use of the Neisseria Multi Locus Sequence Typing website (https://pubmlst.org/ neisseria/) sited at the University of Oxford (Jolley et al. Wellcome Open Res 2018, 3:124 [version 1; referees: 2 approved]). The development of this site has been funded by the Wellcome Trust and European Union. This study made use of Genomic and Bioinformatics ISCIII central Units for genomes sequencing and assembly. We thank all hospitals for sending the strains to the National Reference Laboratory for an IMD laboratory surveillance on a National level. ; Sí

International audience ; Herd protection, resulting from the interruption of transmission and asymptomatic carriage, is an important element of the effectiveness of vaccines against the meningococcus. Whilst this has been well established for conjugate polysaccharide vaccines directed against the meningococcal capsule, two uncertainties surround the potential herd protection provided by the novel protein-based vaccines that are used in place of serogroup B (MenB) polysaccharide vaccines (i) the strain coverage of such vaccines against carried meningococci, which are highly diverse; and (ii) the generation of a protective immune response in the mucosa. These considerations are essential for realistic estimates of cost-effectiveness of new MenB vaccines. Here the first of these questions is addressed by the whole genome sequence (WGS) analysis of meningococci isolated from healthy military recruits and university students in Greece. The study included a total of 71 MenB isolates obtained from 1420 oropharyngeal single swab samples collected from military recruits and university students on voluntary basis, aged 18-26 years. In addition to WGS analysis to identify genetic lineage and vaccine antigen genes, including the Bexsero Antigen Sequence Type (BAST), the isolates were examined with the serological Meningococcal antigen Typing System (MATS) assay. Comparison of these data demonstrated that the carried meningococcal population was highly diverse with 38% of the carriage isolates showed expression of antigens matching those included in the 4CMenB vaccine. Our data may suggest a limited potential herd immunity to be expected and be driven by an impact on a subset of carriage isolates.

International audience ; Herd protection, resulting from the interruption of transmission and asymptomatic carriage, is an important element of the effectiveness of vaccines against the meningococcus. Whilst this has been well established for conjugate polysaccharide vaccines directed against the meningococcal capsule, two uncertainties surround the potential herd protection provided by the novel protein-based vaccines that are used in place of serogroup B (MenB) polysaccharide vaccines (i) the strain coverage of such vaccines against carried meningococci, which are highly diverse; and (ii) the generation of a protective immune response in the mucosa. These considerations are essential for realistic estimates of cost-effectiveness of new MenB vaccines. Here the first of these questions is addressed by the whole genome sequence (WGS) analysis of meningococci isolated from healthy military recruits and university students in Greece. The study included a total of 71 MenB isolates obtained from 1420 oropharyngeal single swab samples collected from military recruits and university students on voluntary basis, aged 18-26 years. In addition to WGS analysis to identify genetic lineage and vaccine antigen genes, including the Bexsero Antigen Sequence Type (BAST), the isolates were examined with the serological Meningococcal antigen Typing System (MATS) assay. Comparison of these data demonstrated that the carried meningococcal population was highly diverse with 38% of the carriage isolates showed expression of antigens matching those included in the 4CMenB vaccine. Our data may suggest a limited potential herd immunity to be expected and be driven by an impact on a subset of carriage isolates.

Herd protection, resulting from the interruption of transmission and asymptomatic carriage, is an important element of the effectiveness of vaccines against the meningococcus. Whilst this has been well established for conjugate polysaccharide vaccines directed against the meningococcal capsule, two uncertainties surround the potential herd protection provided by the novel protein-based vaccines that are used in place of serogroup B (MenB) polysaccharide vaccines (i) the strain coverage of such vaccines against carried meningococci, which are highly diverse; and (ii) the generation of a protective immune response in the mucosa. These considerations are essential for realistic estimates of cost-effectiveness of new MenB vaccines. Here the first of these questions is addressed by the whole genome sequence (WGS) analysis of meningococci isolated from healthy military recruits and university students in Greece. The study included a total of 71 MenB isolates obtained from 1420 oropharyngeal single swab samples collected from military recruits and university students on voluntary basis, aged 18–26 years. In addition to WGS analysis to identify genetic lineage and vaccine antigen genes, including the Bexsero Antigen Sequence Type (BAST), the isolates were examined with the serological Meningococcal antigen Typing System (MATS) assay. Comparison of these data demonstrated that the carried meningococcal population was highly diverse with 38% of the carriage isolates showed expression of antigens matching those included in the 4CMenB vaccine. Our data may suggest a limited potential herd immunity to be expected and be driven by an impact on a subset of carriage isolates.

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.

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

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.

This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of meningococcal vaccines in the United States. As a comprehensive summary and update of previously published recommendations, it replaces all previously published reports and policy notes. This report also contains new recommendations for administration of booster doses of serogroup B meningococcal (MenB) vaccine for persons at increased risk for serogroup B meningococcal disease. These guidelines will be updated as needed on the basis of availability of new data or licensure of new meningococcal vaccines. ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents aged 11 or 12 years, with a booster dose at age 16 years. ACIP also recommends routine vaccination with MenACWY for persons aged ≥2 months at increased risk for meningococcal disease caused by serogroups A, C, W, or Y, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor (e.g., eculizumab [Soliris] or ravulizumab [Ultomiris]); persons who have anatomic or functional asplenia; persons with human immunodeficiency virus infection; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroups A, C, W, or Y; persons who travel to or live in areas in which meningococcal disease is hyperendemic or epidemic; unvaccinated or incompletely vaccinated first-year college students living in residence halls; and military recruits. ACIP recommends MenACWY booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends routine use of MenB vaccine series among persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor; ...

This study aimed to determine social and behavioral predictors of completing a course of 4CMenB vaccine in adolescents in a parallel cluster randomized controlled trial enrolling secondary school students (approximately 15–18 years of age) in South Australia. Participating schools were randomized to vaccination at baseline (intervention) or 12 months (control). Students assigned to the intervention group were excluded because they have received the first dose of 4CMenB vaccine at baseline. Logistic regression models examined factors associated with non-vaccination or incomplete 4CMenB doses. The study population comprised 11391 students. Overall, 8.3% (n = 946) received no doses and 91.7% (n = 10445) at least one dose. Of 10445 students who initiated their primary dose, 1334 (12.8%) did not complete the two-dose course. The final adjusted model indicated factors associated with non-vaccination in school students were older age (adjusted odds ratio; aOR 7.83, 95% CI: 4.13–14.82), smoking cigarettes (aOR 3.24, 95% CI: 1.93–5.44), exposure to passive smoke (aOR 2.64, 95% CI: 1.48–4.71), Aboriginal or Torres Strait Islander (aOR 1.77, 95% CI: 1.23–2.55), smoking water pipes (aOR 1.94, 95% CI:1.28–2.92), low socioeconomic status (aOR 1.77, 95% CI:1.21–2.60), attending government schools (aOR 1.76, 95% CI: 1.28, 2.43) and participating in intimate kissing (aOR 1.40, 95% CI:1.10–1.79). Multivariable analysis for incomplete vaccination yielded similar findings. Social and behavioral predictors of non-vaccination or incomplete MenB doses were also known risk factors for carriage of Neisseria meningitidis. Immunization strategies to improve MenB vaccination completion need to be tailored to social behavior of adolescents.

Background: Several meningococcal vaccines have been recently introduced into the infant and adolescent vaccination schedules in Northern Ireland to promote immunity to protecting against meningococcal septicaemia and meningococcal meningitis. Maintained vaccination uptake is vital in securing individual protection as well as herd immunity. Several social factors have been described in influencing vaccine uptake and therefore it was the aim of this study to examine possible correlations between meningococcal vaccine uptake rates and indicators of social deprivation in Northern Ireland. Methods: Vaccination data was retrieved from the Cover of Vaccination Evaluated Rapidly (COVER) database, for meningococcal vaccines (MenACWY, HiB/MenC & 4CMenB, as well as for MMR vaccine as a non-meningococcal control). Vaccine coverage data assessed included (i). Two doses of MenB by 12 months, (ii). All 3 doses of MenB by 24 months, (iii). HiB/MenC coverage, (iv). MenACWY (Year 12s, for NI) (v). First dose of MMR. Northern Ireland Multiple Deprivation Measures 2017 (NIMDM2017) were examined against 38 indicators in 7 domains. NI HSCT vaccine uptake dataset for each vaccine was correlated with each indicator in the HSCT NIMDM2017 dataset. Regression analysis was performed to determine the relationship between vaccine uptake and deprivation indicators and coefficient of variation (R ) was calculated for each of the indicators. R values >0.7 were considered significant. Results: For 4CMenB (all 3 doses by 24 Months), HiB/MenC, MenACWY and for MMR, correlation of variation (R ) values > 0.7, were obtained for 17, 16, 0 and 17 social deprivation indicators, respectively. Significant deprivation indicators were (i) the proportion of 18-21 year olds, who have not enrolled in higher education courses at higher or further education establishments, (ii) the proportion of domestic dwellings that are unfit, (iii) the proportion of domestic dwellings with Local Area Problem Scores, (iv) rate of burglary, (v) rate of vehicle crime, (vi) rate of antisocial behaviour incidents (per 1,000 population), (vii) absenteeism at primary schools and (viii) the proportion of the population aged 65 and over living in households whose equivalised income is below 60% of the NI median. Conclusion: Within the last two decades, incidence of meningococcal disease has been on the decline. The introduction of meningococcal vaccines has contributed to this decrease and uptake of such vaccines should remain a public health priority to maintain the decline in meningococcal disease. Identifying contributing factors to low vaccine uptake, such as, the association between local deprivation and uptake of meningococcal vaccines, should be of public health importance and acknowledged by local governments and policy makers in their efforts to enhance vaccine uptake, both infant and teenage vaccination. There is a clear correlation with educational deprivation measures such as absenteeism and poor educational attainment and reduced vaccine uptake, perhaps through lack of understanding and willingness to vaccinate. This is where the importance of a clear and coherent public health message surrounding meningococcal vaccination should be prioritised, particularly to establish innovative modalities in a multidisciplinary team approach, to reach out to and increase vaccine uptake rates in socially deprived communities in Northern Ireland.