Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

The Chinese University of Hong Kong

Status and phase: Active, not recruiting; Phase 3

Conditions: Gonorrhea; Sexually Transmitted Infection

Treatments: Other: Placebo; Biological: 4CMenB vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05766904

21200912

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Biological: 4CMenB vaccine

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo