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Gonococcal Vaccine Research

A Randomized, Placebo-Controlled, Double-Blind, Comparative Trial of Group B Meningococcal Vaccine for the Prevention of Gonococcal Infections in men who have sex with men (MSM).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240617
Enrollment
800
Registered
2025-01-16
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonococcal Infections Gonococcal Infections

Interventions

Group B meningococcal vaccine Bexsero will be administered on the date of enrollment in the study, with a second dose 4 weeks later. Sexually transmitted disease testing will be performed every 3 mont
C570015

Sponsors

Aoki Takahiro
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1)Adult MSM aged 18 years or older who are regular attendees at ACC or SH outpatient clinics (2)Patients with a history of bacterial STI (syphilis, gonorrhea, or chlamydia) in the past 2 years (3) Those who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: (1)Those who are allergic to meningococcal B vaccine Bexsero (2)Patients with contraindications to intramuscular injection of the vaccine due to abnormalities in the blood coagulation system, etc. (3)Patients with a history of Bexsero administration (4)gonococcal infection positive at screening (5) Other conditions that make participation in the study inappropriate for the patient.

Design outcomes

Primary

MeasureTime frame
Preventive efficacy of group B meningococcal vaccine Bexsero in preventing gonococcal infections.

Secondary

MeasureTime frame
Effect of Bexsero prophylaxis on other bacterial STIs. VE in the presence of overlapping other bacterial STIs. VE in the presence of HIV infection. Collecting Bexsero adverse events.

Contacts

Public ContactTakahiro Aoki

National Center for Global Health and Medicine

taoki@acc.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026