Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine : results from a randomized, controlled, observer-blind study in adolescents and young adult

A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10-40 years). In part 1, 844 participants received one dose of liquid presentation stored for approximately 24 months or licensed presentation. In part 2, 846 participants received one dose of liquid presentation stored for approximately 30 months or licensed presentation. After storage, the MenA free saccharide (FS) level was approximately 25% and O-acetylation was approximately 45%. The primary objective was to demonstrate non-inferiority of the liquid presentation to licensed presentation, as measured by human serum bactericidal assay (hSBA) geometric mean titers (GMTs) against MenA, 1-month post-vaccination. Immune responses against each vaccine serogroup were similar between groups. Between-group ratios of hSBA GMTs for MenA were 1.21 (part 1) and 1.11 (part 2), with two-sided 95% confidence interval lower limits (0.94 and 0.87, respectively) greater than the prespecified non-inferiority margin (0.5), thus meeting the primary study objective. No safety concerns were identified. Despite reduced O-acetylation of MenA and increased FS content, serogroup-specific immune responses induced by the fully liquid presentation were similar to those induced by the licensed MenACWY-CRM vaccine, with non-inferior anti-MenA responses. The safety profiles of the vaccine presentations were similar.GlaxoSmithKline Biologicals SAhttps://www.tandfonline.com/journals/KHVIMedical Microbiolog

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial.

We construct the classical configurations of BPS states with 1/4 unbrokensupersymmetries in four-dimensional N=4 SU(n+1) supersymmetric Yang-Millstheory, and discuss that these configurations correspond to string networksconnecting (n+1) D3-branes in Type IIB string theory

4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults

Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis, is life-threatening but can be prevented with vaccination. There are effective vaccines against different meningococcal serogroups, including serogroup B. Evidence from immunization programs with the 4-component meningococcal serogroup B vaccine, 4CMenB, over the past decade confirms its effectiveness and positive impact against serogroup B disease in people of all age groups. To assess the performance of serogroup B vaccines in clinical trials, tests are required that take into account the wide diversity of serogroup B strains circulating in the population. In this study, the performance of 4CMenB was evaluated using the enc-hSBA assay, which uses the complement (proteins) present in each vaccinated person's blood and is used to test a large number of N meningitidis strains, thereby determining breadth of immune response, based on the vaccine's killing activity against diverse strains. Using this assay, our results showed breadth of immune response following administration of 4CMenB (2 doses, 2 or 6 months apart) against the 110 serogroup B strains tested that was consistent with its performance in immunization programs, with no additional benefit from administering 3 4CMenB doses over the 6-month period. The safety of 4CMenB was consistent with its known safety profile.Clinical Trial Registration. NCT04502693