Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection

Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection Published July 8, 2026 N Engl J Med 2026;395:349-361 DOI: 10.1056/NEJMoa2516739 Abstract Background No vaccines are currently licensed for the prevention of Neisseria gonorrhoeae infection. Observational studies suggest that the four-component meningococcal serogroup B vaccine (4CMenB) may reduce the risk of gonorrhea. Methods In this multicenter, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, men who have sex with men (MSM) to receive two doses of 4CMenB or placebo. All the participants had recently received a diagnosis of N. gonorrhoeae infection or infectious syphilis and either tested negative for human immunodeficiency virus (HIV) and were receiving HIV preexposure prophylaxis or were living with HIV. Screening for sexually transmitted infections, including N. gonorrhoeae nucleic acid amplification testing of samples obtained from urogenital, anorectal, and oropharyngeal sites, was performed quarterly for 2 years. The primary outcome was a first N. gonorrhoeae infection after the receipt of vaccine or placebo in the per-protocol population (participants who received both 4CMenB or placebo doses, attended at least two scheduled follow-up visits after the second dose, and did not meet any exclusion criterion pertinent to the assessment of efficacy). Results From July 2021 through May 2023, a total of 654 participants underwent randomization, of whom 587 were included in the primary analysis. The incidence of N. gonorrhoeae infection was 48.1 events per 100 person-years (160 events among 296 participants) in the 4CMenB group and 47.8 events per 100 person-years (155 events among 291 participants) in the placebo group (incidence rate ratio, 1.01; 95% confidence interval [CI], 0.80 to 1.26; P=0.97), for a vaccine efficacy of −0.5% (95% CI, −26.2 to 19.9). Vaccine efficacy was 5.5% (95% CI, −56.0 to 42.8) for symptomatic infection, −6.4% (95% CI, −47.5 to 23.2) for asymptomatic infection, and −20.0% (95% CI, −90.2 to 23.9), −1.2% (95% CI, −33.0 to 23.0), and 2.6% (95% CI, −27.7 to 25.7) for urogenital, anorectal, and oropharyngeal infection, respectively. Serious adverse events occurred in 4.7% of the participants in the 4CMenB group and in 2.8% of those in the placebo group. Conclusions 4CMenB did not result in a lower incidence of N. gonorrhoeae infection than placebo among MSM who were at high risk for gonorrhea. (Funded by the Australian National Health and Medical Research Council and GSK; GoGoVax ClinicalTrials.gov number, NCT04415424.) Are you a member of an institution such as a university or hospital?Learn more about Institutional Access Notes This article was published on July 8, 2026, at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Supported by a grant (GNT1182443) from the Australian National Health and Medical Research Council and by GSK. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. We thank the members of the GoGoVax Protocol Steering Committee not already listed as authors; the nonauthor coinvestigators and coordinators, pharmacists, drug managers, and clinical and laboratory staff at the trial sites; and the trial participants. Supplementary Material Information & Authors Information Published In Copyright Copyright © 2026 Massachusetts Medical Society. All rights reserved. For personal use only. Any commercial reuse of NEJM Group content requires permission. History Published online: July 8, 2026 Published in issue: July 23, 2026 Topics Authors Metrics & Citations Metrics Altmetrics Citations Export citation Select the format you want to export the citation of this publication. Cited by - Gonorrhoea vaccine: Australian study suggests England’s “world first” rollout may not work, BMJ, 394, (e100281), (2026).https://doi.org/10.1136/bmj-2026-100281 Loading...