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Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men
Sponsor: Kirby Institute
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
Conditions
Interventions
4CMenB vaccine
A four-component meningococcal B vaccine
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