Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men (NCT04415424) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men
Australia650 participantsStarted 2021-07-08
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Between 18 to ≤ 50 years of age
✓. Men (cis and trans), trans women and non-binary people who have had sex with at least one man in the last 6 months
✓. Diagnosis of gonorrhoea or infectious syphilis in the last 18 months
✓. Committed not to take doxycycline as prophylaxis for the duration of the trial
✓. Able to understand spoken and written English
✓. Willing and likely to comply with the trial procedures for 2 years
✓. Agree to be contacted via short message service (SMS)/phone/ email by the study team
✓. HIV-negative (with an HIV negative antibody test within 4 months of screening) and taking HIV PrEP (daily PrEP or on-demand PrEP) within the last 4 months at the time of enrolment or
Exclusion criteria
✕. Have a previous history of vaccination for meningococcal B with 4CMenB
What they're measuring
1
To measure whether the 4CMenB vaccine, when administered in a 2-dose regimen at 0 and 3 months, changes the incidence of the first episode of N. gonorrhoeae.
Timeframe: From Month 4 to Month 24
2
To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms.
. Have contraindications to receiving the meningococcal B vaccine which include:
✕. Are participating in biomedical prevention strategies for bacterial STIs (participation in diagnostic or treatment studies is not an exclusion)
✕. Are taking long-term (\> 4 weeks) antibiotic for prophylaxis or treatment for acne, malaria, syphilis or other bacterial condition(s)
✕. Have defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency
✕. Are taking or will receive complement inhibitors such as eculizumab (a monoclonal antibody directed against complement component C5) or ravulizumab
✕. Have functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia
✕. Have had a haematopoietic stem cell transplant