NCT05766904

Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Efficacy of a Meningococcal B Vaccine Against Neisseria Gonorrhoeae Infections Among Men Who Have Sex With Men: a Randomised-controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM). Design: Parallel randomised double-blind placebo-controlled trial. Setting: A teaching hospital in Hong Kong. Participants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transmitted infection \[STI\] diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria) would be recruited into the trial, with half allocated to intervention and control group each. Intervention: Intervention and control group would receive, one month apart, two doses of meningococcal vaccine and normal saline, respectively. Main outcome measures: Safety and efficacy of vaccine against gonorrhoea (time to first gonorrhoea infection and incidence), and behavioural change after vaccination. Expected results: NG incidences in two groups would be compared. Efficacy of vaccine against gonorrhoea would be determined after controlling confounding variables. Characteristics of participants with incident NG would be distinguished from those without incident infections. Change of frequency of sexual activities and networking would be noted. Implications: Strategies on STI screening and vaccination could be informed. Reduced STI burden post-vaccination could be measured with surveillance system.

Conditions

• Gonorrhea
• Sexually Transmitted Infection

Interventions

Type	Name	Description
BIOLOGICAL	4CMenB vaccine	Four-component MenB vaccine
OTHER	Placebo	0.9% Sodium Chloride Inj. B.P.

Timeline

• Start date: 2023-05-04
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-03-13
• Last updated: 2026-03-19

Locations

1 site across 1 country: Hong Kong