Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection

作者：Kate L. Seib, B Donovan, Fengyi Jin, Caroline Thng, Barbara Yeung, Nicholas Comninos, Rohan I. Bopage, Anik Ray, Alison Mahony, Eric P. F. Chow, M S Chen, Kate Maddaford, Helen Lau, Portia Westall, Dan Lu, Benjamin R. Bavinton, Kathy Petoumenos, David M. Whiley, Michael P. Jennings, Amy V. Jennison, Kaldor Jm, R Guy, Monica M. Lahra, Jane Costello, Brent Mackie, David J. Templeton, Beng Eu, Mark O’Reilly, Christopher K. Fairley, Anna McNulty, Rick Varma, David A. Lewis, Andrew E. Grulich · 发表于：New England Journal of Medicine · 年份：2026 · DOI：10.1056/nejmoa2516739 · 被引用次数：7 · 研究领域：Bacterial Infections and Vaccines、Reproductive tract infections research、Virology and Viral Diseases

BackgroundNo 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. MethodsIn 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). ResultsFrom 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 4...