Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Phase 3

Recruiting

• Conditions: Gonorrhea; Sexually Transmitted Infection
• Interventions: Biological: 4CMenB vaccine; Other: Placebo

• Registration Number: NCT05766904
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-13
• Status Verified: 2023-05
• Study Start: 2023-05-04
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• Male adult who has had sex with another male in the past six months
• Ages 18 years or above
• Normally resides in Hong Kong
• Able to communicate in written and spoken Chinese or English
• At risk of gonorrhoea infection (had condomless sex with more than one man within the last six months, history of STI diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria)
• Negative NG test result at the time of recruitment
• No history of previous vaccination with MenB vaccines
• Able and willing to attend all study visits

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Exclusion Criteria

• Contraindications to receive MenB vaccine
• Unable to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	4CMenB vaccine	Intramuscular injection of 2 doses of 0.5mL 4CMenB vaccine 1 month apart
Control	Placebo	Intramuscular injection of 2 doses of 0.5mL placebo 1 month apart

Primary Outcome Measures

Name	Time	Method
Comparison between incidence of NG between two groups	Month 2 to Month 24	Difference in NG incidences in the two groups

Secondary Outcome Measures

Name	Time	Method
Changes in risk behaviours and networking pattern after vaccination	Month 2 to Month 24	Frequency of sex networking, number of sex partners, and use of condoms
Safety profile of the vaccine	Month 2 to Month 24	Prevalence of adverse events

Trial Locations

Locations (1)

Stanley Ho Centre for Emerging Infectious Diseases; 🇭🇰 Sha Tin, Hong Kong