Active — Not RecruitingPhase 3

BIYELA - Bexsero Immunisation in Young Women in Africa

South Africa1,100 participantsStarted 2024-08-14

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. If not living with HIV, negative HIV test conducted at screening
✓. If living with HIV, on an antiretroviral regimen for ≥3 months, with an undetectable HIV RNA of \<200 copies/ml and/or a CD4 count \>300 cells/cmm within 12 months of screening
✓. Willing to not become pregnant during vaccination period and
✓. Have a negative pregnancy test prior to each vaccination and
✓. Willing to use a reliable method of contraception until month 3 (i.e., after the second vaccination visit)
✓. Not breastfeeding
✓. Previous PrEP use in the past 12 months, or
✓. Past history of STIs in the past 12 months, or

What they're measuring

First diagnosis of gonorrhea at cervical or anorectal sites occurring greater than or equal to 1 month after the second vaccination with study product through to the study end

Timeframe: 18 months

Trial details

NCT IDNCT06446752

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Gonorrhea trials