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

Summary

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.

Timeline

Start

2021-07-08

Primary completion

2025-06-30

Completion

2025-10-30

Publications

• Seib KL, Donovan B, Jin F, Thng C, Yeung B, Comninos N, Bopage RI, Ray A, Mahony A, Chow EPF, Chen MY, Maddaford K, Lau H, Westall P, Lu D, Bavinton BR, Petoumenos K, Whiley DM, Jennings MP, Jennison AV, Kaldor J, Guy R, Lahra MM, Costello J, Mackie B, Templeton DJ, Eu B, O'Reilly M, Fairley CK, McNulty A, Varma R, Lewis DA, Grulich AE; GoGoVax Study Team. Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection. N Engl J Med. 2026 Jul 8. doi: 10.1056/NEJMoa2516739. Online ahead of print.
• Seib KL, Donovan B, Thng C, Lewis DA, McNulty A, Fairley CK, Yeung B, Jin F, Fraser D, Bavinton BR, Law M, Chen MY, Chow EPF, Whiley DM, Mackie B, Jennings MP, Jennison AV, Lahra MM, Grulich AE. Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol. BMJ Open. 2024 Apr 16;14(4):e081675. doi: 10.1136/bmjopen-2023-081675.

Drugs

Indications