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MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies.

ABSTRACT: INTRODUCTION:Two phase 3 studies in adolescents and young adults demonstrated that MenB-FHbp, a meningococcal serogroup B (MenB) vaccine, elicits protective immune responses after 2 or 3 doses based on serum bactericidal antibody assays using human complement (hSBA) against 4 primary and 10 additional diverse, vaccine-heterologous MenB test strains. Lower limits of quantitation (LLOQs; titers 1:8 or 1:16; titers???1:4 correlate with protection) were used to evaluate responses to individual strains and all 4 primary strains combined (composite response). A post hoc analysis evaluated percentages of subjects with protective responses to as many as 8 strains combined (4 primary plus additional strains). METHODS:Immune responses were measured using hSBAs against 4 primary strains in adolescents (n?=?1509, MenB-FHbp; n?=?898, hepatitis A virus vaccine/saline) and young adults (n?=?2480, MenB-FHbp; n?=?824, saline) receiving MenB-FHbp or control at 0, 2, and 6 months. Ten additional strains were evaluated in subsets of subjects from approximately 1800 MenB-FHbp recipients across both studies. Percentages of subjects with hSBA titers???LLOQ for different numbers of primary strains or primary plus additional strains combined (7 or 8 strains total per subset) were determined before vaccination, 1 month post-dose 2, and 1 month post-dose 3. RESULTS:Across the panel of primary plus additional strains, at 1 month post-dose 3, titers???LLOQ were elicited in 93.7-95.7% of adolescents and 91.7-95.0% of young adults for???5 test strains combined and in 70.5-85.8% of adolescents and 67.5-81.4% of young adults for???7 strains combined. Among adolescents, 99.8%, 99.0%, 92.8%, and 82.7% had titers???LLOQ against at least 1, 2, 3, and all 4 primary strains, respectively; corresponding percentages for young adults were 99.7%, 97.7%, 94.0%, and 84.5%. CONCLUSIONS:Results support the ability of MenB-FHbp to provide broad coverage against MenB strains expressing diverse FHbp variants. TRIAL REGISTRATION:ClinicalTrials.gov identifiers NCT01830855, NCT01352845.

SUBMITTER: Beeslaar J

PROVIDER: S-EPMC7452968 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies.

Beeslaar Johannes J Absalon Judith J Anderson Annaliesa S AS Eiden Joseph J JJ Balmer Paul P Harris Shannon L SL Jones Thomas R TR O'Neill Robert E RE Pregaldien Jean-Louis JL Radley David D Maansson Roger R Ginis John J Srivastava Amit A Perez John L JL

Infectious diseases and therapy 20200722 3

<h4>Introduction</h4>Two phase 3 studies in adolescents and young adults demonstrated that MenB-FHbp, a meningococcal serogroup B (MenB) vaccine, elicits protective immune responses after 2 or 3 doses based on serum bactericidal antibody assays using human complement (hSBA) against 4 primary and 10 additional diverse, vaccine-heterologous MenB test strains. Lower limits of quantitation (LLOQs; titers 1:8 or 1:16; titers ≥ 1:4 correlate with protection) were used to evaluate responses to individu ...[more]

PMID: 32700260

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Project description:(1) To explore existing knowledge of, and attitudes, to group B meningococcal disease and serogroup B meningococcal (MenB) vaccine among parents of young children. (2) To seek views on their information needs.Cross-sectional qualitative study using individual and group interviews conducted in February and March 2015, prior to the introduction of MenB vaccine (Bexsero) into the UK childhood immunisation schedule.Community centres, mother and toddler groups, parents' homes and workplaces in London and Yorkshire.60 parents of children under 2?years of age recruited via mother and baby groups and via an advert posted to a midwife-led Facebook group.Although recognising the severity of meningitis and septicaemia, parents' knowledge of group B meningococcal disease and MenB vaccine was poor. While nervous about fever, most said they would take their child for MenB vaccination despite its link to fever. Most parents had liquid paracetamol at home. Many were willing to administer it after MenB vaccination as a preventive measure, although some had concerns. There were mixed views on the acceptability of four vaccinations at the 12-month booster visit; some preferred one visit, while others favoured spreading the vaccines over two visits. Parents were clear on the information they required before attending the immunisation appointment.The successful implementation of the MenB vaccination programme depends on its acceptance by parents. In view of parents' recognition of the severity of meningitis and septicaemia, and successful introduction of other vaccines to prevent bacterial meningitis and septicaemia, the MenB vaccination programme is likely to be successful. However, the need for additional injections, the likelihood of post-immunisation fever and its management are issues about which parents will need information and reassurance from healthcare professionals. Public Health England has developed written information for parents, informed by these findings.

Project description:INTRODUCTION:Capsular group B Neisseria meningitidis (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B 'substitute' vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal Neisseria spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease. METHODS AND ANALYSIS:The 'Be on the TEAM' (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24?000 students aged 16-19?years in their penultimate year of secondary school across the UK with regional allocation to a 0+6?month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other Neisseria spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development. ETHICS AND DISSEMINATION:This study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools. TRIAL REGISTRATION NUMBERS:ISRCTN75858406; Pre-results, EudraCT 2017-004609-42.

Project description:ObjectiveTo assess the efficacy of a selective, personality-targeted intervention for reducing suicidal ideation in adolescents.DesignPost hoc analysis of survey data collected in the Climate and Preventure (CAP) study, a cluster randomised controlled trial that compared strategies for reducing alcohol misuse by adolescents, 2012-2015.Setting, participantsYear 8 students at 16 New South Wales non-government schools and one Victorian non-government school.InterventionPreventure, a selective, personality-targeted intervention designed to help adolescents with personality risk factors for alcohol misuse, comprising two 90-minute sessions, one week apart. For our post hoc analysis, we combined data from the two CAP trial groups in which Preventure was offered (the Preventure and the Preventure/Climate Schools [a non-selective prevention strategy] groups) as the intervention group; and data from the two groups in which Preventure was not offered (usual health education only [control] and Climate Schools groups) as the control group.Main outcome measureDifference between post hoc control and intervention groups in the change in proportions of students reporting suicidal ideation during the preceding six months (single item of Brief Symptom Inventory depression subscale) over three years.ResultsA total of 1636 students (mean age at baseline, 13.3 years; standard deviation, 0.5 years) were included in our analysis, of whom 1087 (66%) completed the suicidal ideation item in the three-year follow-up assessment. The post hoc control group included 755 students (nine schools), the intervention group 881 students (eight schools). After adjusting for nesting of students in schools and sex, reporting of suicidal ideation by students who had received Preventure had declined over three years, compared with the control group (per year: adjusted odds ratio, 0.80; 95% CI, 0.66-0.97).ConclusionPersonality-targeted selective prevention during early secondary school can have a lasting impact on suicidal ideation during adolescence.Trial registration (cap study only)Australian and New Zealand Clinical Trials Registry, ACTRN12612000026820 (prospective).

Dataset Information

MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies.

Publications

MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies.

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