Efficacy Trial on Meningococcal B Vaccine for Preventing... | NCT05766904

Studies
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

NCT05766904

Sponsor

Chinese University of Hong Kong

Status

Active, not recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

150Estimated

Phase

Phase 3

Conditions

Gonorrhea
Sexually Transmitted Infection

Interventions

4CMenB vaccine
Placebo

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2023Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 1, 2023

First Submission Date that Met QC Criteria

Mar 11, 2023

First Posted Date

Mar 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tsz Ho Kwan, Research Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
4CMenB vaccine	Biological	Four-component MenB vaccine	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between incidence of NG between two groups	Difference in NG incidences in the two groups	Month 2 to Month 24

Secondary Outcomes

Measure	Description	Time Frame
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
Safety profile of the vaccine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsz Ho Kwan, PhD	Jockey Club School of Public Health and Primary Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanley Ho Centre for Emerging Infectious Diseases		Shatin			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D006069	Gonorrhea
D012749	Sexually Transmitted Diseases

Ancestor Terms

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570015	4CMenB vaccine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.

Masking Info

Masking

Quadruple

Masking Description

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.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor