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NCT Number: NCT05766904

Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gonorrhea Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Genital Diseases Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Infection Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

4CMenB vaccine

Biological

Four-component MenB vaccine

Other names: Bexsero

Placebo

Other

0.9% Sodium Chloride Inj. B.P.

Primary outcomes

  1. Comparison between incidence of NG between two groups

    Time frame: Month 2 to Month 24

    Difference in NG incidences in the two groups

Secondary outcomes

  1. Changes in risk behaviours and networking pattern after vaccination

    Time frame: Month 2 to Month 24

    Frequency of sex networking, number of sex partners, and use of condoms

  2. Safety profile of the vaccine

    Time frame: Month 2 to Month 24

    Prevalence of adverse events

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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