Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Last updated: April 2, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hiv

Gynecological Infections

Vaginal Infection

Treatment

Placebo

4CMenB vaccine

Clinical Study ID

NCT05766904
21200912
  • Ages 18-50
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 withinthe 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

Exclusion

Exclusion Criteria:

  • Contraindications to receive MenB vaccine

  • Unable to give informed consent

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 04, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Stanley Ho Centre for Emerging Infectious Diseases

    Sha Tin,
    Hong Kong

    Site Not Available

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