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

NCT04415424 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-03-24

No results posted yet for this study

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.

Conditions

  • Neisseria Gonorrheae Infection

Interventions

BIOLOGICAL

4CMenB vaccine

A four-component meningococcal B vaccine

OTHER

Placebo

0.5 ml of 150 mmol sodium chloride (0.9% saline solution)

Sponsors & Collaborators

  • Griffith University

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Professor Kate Seib, BSc(Hon),PhD · Institute for Glycomics, Griffith University, Queensland, Australia

  • Professor Basil Donovan, MBBS, MD · The Kirby Institute, University of New South Wales Sydney, Australia

  • Professor Andrew Grulich, MBBS, PhD · The Kirby Institute, University of New South Wales Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415424 on ClinicalTrials.gov