Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ \[GBM+\], either HIV-negative and taking pre-exposure prophylaxis \[PrEP\], or HIV-positive with undetectable viral load \<200copies/ml and a cluster of differentiation 4 \[CD4\] count \>350 cells/cmm) who have high N. gonorrhoeae incidence and are recommended by Australian guidelines to have regular, comprehensive sexual health screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment is for 12 months and all participants will be follow-up 3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.

NCT Number	NCT04415424
Lead Sponsor	Kirby Institute Collaborators: Griffith University
Conditions	Neisseria Gonorrheae Infection
Enrollment	650 participants
Start Date	2021-07-08
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-10-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-24