Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766904
• Other study ID #: 21200912
• Status: Recruiting
• Phase: Phase 3
• Start date: May 4, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Secretariat
• Phone: 22528812
• Email: ceid[@]med.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gonorrhea
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

Biological:
• 4CMenB vaccine
Four-component MenB vaccine

Other:
• Placebo
0.9% Sodium Chloride Inj. B.P.

Locations

Country	Name	City	State
Hong Kong	Stanley Ho Centre for Emerging Infectious Diseases	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between incidence of NG between two groups	Difference in NG incidences in the two groups	Month 2 to Month 24
Secondary	Changes in risk behaviours and networking pattern after vaccination	Frequency of sex networking, number of sex partners, and use of condoms	Month 2 to Month 24
Secondary	Safety profile of the vaccine	Prevalence of adverse events	Month 2 to Month 24