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ACTIVE NOT RECRUITING
NCT04415424
PHASE3

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

Sponsor: Kirby Institute

View on ClinicalTrials.gov

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.

Official title: A Multi-centre Randomised Controlled Trial Evaluating the Efficacy of the Four-component Meningococcal B Vaccine, 4CMenB (Bexsero®), in the Prevention of Neisseria Gonorrhoeae Infection in Gay and Bisexual Men

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2021-07-08

Completion Date

2025-10-30

Last Updated

2025-03-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

4CMenB vaccine

A four-component meningococcal B vaccine

OTHER

Placebo

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

Locations (7)

Western Sydney Sexual Health Centre

Parramatta, New South Wales, Australia

Sydney Sexual Health Centre

Sydney, New South Wales, Australia

Taylor Square Private Clinic

Sydney, New South Wales, Australia

RPA Sexual Health

Sydney, New South Wales, Australia

Gold Coast Sexual Health Service

Southport, Queensland, Australia

Melbourne Sexual Health Centre

Carlton, Victoria, Australia

Prahran Market Clinic

Melbourne, Victoria, Australia