Clinical trialNCT06446752Active, not recruitingPhase 3Interventional

BIYELA - Bexsero Immunisation in Young Women in Africa

SponsorUniversity of WashingtonEnrollment1,100GonorrheaGonorrhea of AnusGonorrhea of CervixGonorrhea of Pharynx

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This proposed 2-arm randomized evaluation of two doses of 4CMenB vaccine versus placebo at Enrollment and Month 2 is designed as a proof-of-concept study to inform potential use for dual meningococcal B and gonococcal prevention, and to inform Neisseria gonorrheae vaccine development.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Connie Celum, MD, MPH
University of Washington
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

South Africa

Desmond Tutu Health Foundation - Emavundleni Research Centre
Cape Town, South Africa
Desmond Tutu Health Foundation - Masiphumulele Site
Cape Town, South Africa
Khayelitsha Vuka Research Clinic
Cape Town, South Africa
Wits Rhi Ward 21 Clinical Research Site
Johannesburg, South Africa
Center for Community Based Research (ccbr)
Pietermaritzburg, South Africa

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bexsero →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 14 Aug 2024
Primary completion: 31 Oct 2026
Completion: 31 Jan 2027
Last update posted: 10 Jul 2025
Registered enrollment: 1,100
Registry id: NCT06446752

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.