Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

NCT05766904 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 21200912
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonorrhea; Sexually Transmitted Infection

Outcome Measures

Primary Outcomes (1)

• Comparison between incidence of NG between two groups

  Difference in NG incidences in the two groups

  Month 2 to Month 24

Secondary Outcomes (2)

• Changes in risk behaviours and networking pattern after vaccination

  Month 2 to Month 24

• Safety profile of the vaccine

  Month 2 to Month 24

Study Arms (2)

Intervention

EXPERIMENTAL

Intramuscular injection of 2 doses of 0.5mL 4CMenB vaccine 1 month apart

Biological: 4CMenB vaccine

Control

PLACEBO COMPARATOR

Intramuscular injection of 2 doses of 0.5mL placebo 1 month apart

Other: Placebo

Interventions

4CMenB vaccine BIOLOGICAL

Four-component MenB vaccine

Also known as: Bexsero

Intervention

Placebo OTHER

0.9% Sodium Chloride Inj. B.P.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Gonorrhea; Sexually Transmitted Diseases

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Tsz Ho Kwan, PhD

  Jockey Club School of Public Health and Primary Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomisation would be used to generate the list of treatment groups with a block size of 4 in a centralised computer by a staff in the Research Centre unrelated to data analysis. Group assignment would be concealed and performed by another staff unrelated to data analysis who will pick the group number from the random allocation sequence in sequential order. The subjects and investigators would therefore be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Participants in the vaccination group would receive two doses of 4CMenB vaccine 1 month apart (at Month 0 and Month 1) while subjects in the control group would receive two doses of normal saline of a similar volume.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: May 4, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

HK (1)