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

Study acronym: GoGoVax
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 24, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Oct 2024 to Jun 30, 2025
    • Enrollment target: 652 to 650
    • Study completion date: Feb 2025 to Oct 30, 2025
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 730 to confirmed 652
    • Site details revised at 7 of 7 sites
    v6
  3. Study sites: 4 to 7
    • Eligibility criteria revised
    v5
  4. Primary completion date: Oct 2023 to Oct 2024
    • Study completion date: Feb 2024 to Feb 2025
    v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date changed from estimate of Apr 2021 to Jul 8, 2021
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints revised (3)
    • Study description revised
    • Site details revised at 4 of 4 sites
  6. Start date: Oct 2020 to Apr 2021v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04415424
Lead Sponsor Kirby Institute
Collaborators: Griffith University
Conditions
(from sponsor)		 Neisseria Gonorrheae Infection
Related terms Gonorrhea
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov