Background: Outer membrane vesicle (OMV) meningococcal serogroup B (MenB) vaccines might be protective against gonorrhea. We evaluated the effectiveness of MenB-4C, an OMV MenB vaccine, against gonorrhea.
Methods: We identified gonococcal mono-infections, chlamydial mono-infections, and gonococcal/chlamydial co-infections among persons aged 15-30 years in the electronic health records of Kaiser Permanente Northern California during 2016-2021. We determined MenB-4C vaccination status (vaccinated [≥1 MenB-4C vaccine dose] or unvaccinated [MenB-4C vaccine naïve]) at each infection. We used log-binomial regression with generalized estimating equations to calculate adjusted prevalence ratios (APR) and 95 % confidence intervals (CI) to determine if MenB-4C vaccination was protective against gonococcal mono-infections compared to chlamydial mono-infection. We also evaluated if MenB-4C vaccination was protective against gonococcal/chlamydial co-infections. Because of concerns with small sample size of vaccinated persons, we estimated effects using a limited model (adjusting for race/ethnicity only) and an expanded model (adjusting for additional potential confounders).
Results: Of 68,454 persons, we identified 558 (0.8 %) MenB-4C vaccinated persons and 85,393 infections (13,000 gonococcal mono-infections, 68,008 chlamydial mono-infections, and 4385 gonococcal/chlamydial co-infections). After adjusting for race/ethnicity, MenB-4C vaccination was 23 % protective against gonococcal mono-infection compared to chlamydial mono-infection (APR = 0.77, 95 % CI = 0.64-0.99) in the limited model but not in the expanded model.
Conclusion: MenB-4C vaccination was protective against gonococcal mono-infection, independent of race/ethnicity. This protective effect was not observed when other potential confounders were included in the analysis. Protection against gonococcal/chlamydial co-infection was not observed. Efficacy data from clinical trials are needed.
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http://dx.doi.org/10.1016/j.vaccine.2024.126312 | DOI Listing |
Two meningococcal serogroup B vaccines are licensed for use in the United States. In August 2024, the Food and Drug Administration (FDA) changed the label for the meningococcal serogroup B MenB-4C vaccine (Bexsero) from a 2-dose schedule (intervals of 0 and ≥1 month) to a 2-dose schedule (0 and 6 months) and added a 3-dose schedule (0, 1-2, and 6 months), based on new immunogenicity data. On October 24, 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendations for the MenB-4C dosing interval and schedule to align with the new FDA label.
View Article and Find Full Text PDFVaccine
December 2024
Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States.
J Infect Dis
July 2024
Division of STD Prevention, U.S Centers for Disease control and Prevention, Atlanta, Georgia 30333 United States of America.
Meningococcal disease is a life-threatening invasive infection caused by Neisseria meningitidis. Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP).
View Article and Find Full Text PDFFront Immunol
March 2024
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States.
Introduction: Outer membrane vesicles (OMVs) of in the group B-directed vaccine MenB-4C (Bexsero) protect against infections with . The immunological basis for protection remains unclear. OMV vaccines generate human antibodies to and lipooligosaccharide (LOS/endotoxin), but the structural specificity of these LOS antibodies is not defined.
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