Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gonorrhea Sexually Transmitted Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

4CMenB vaccine

Intervention Type BIOLOGICAL

Four-component MenB vaccine

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0.9% Sodium Chloride Inj. B.P.

Interventions

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4CMenB vaccine

Four-component MenB vaccine

Intervention Type BIOLOGICAL

Placebo

0.9% Sodium Chloride Inj. B.P.

Intervention Type OTHER

Other Intervention Names

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Bexsero

Eligibility Criteria

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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