Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
NCT06436274 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 778
Last updated 2026-01-12
Summary
The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.
Conditions
Interventions
- BIOLOGICAL
-
GARDASIL®9
GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
- BIOLOGICAL
-
Menveo®/Menactra®
Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
Sponsors & Collaborators
-
University of Witwatersrand, South Africa
collaborator OTHER -
Botswana Harvard Health Partnership
collaborator UNKNOWN -
Ministry of Health, Rwanda
collaborator OTHER_GOV -
Fred Hutchinson Cancer Center
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH - collaborator OTHER
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Ruanne Barnabas, MBChB, MSc, DPhil · Massachusetts General Hospital
-
Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H · Wits RHI, University of The Witwatersrand
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 16 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-14
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
Countries
- Botswana
- Rwanda
- South Africa
Study Locations
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