HPV vaccination to prevent infection in women living with HIV
Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
This study is testing if a single dose of a new HPV vaccine can help women living with HIV who have already been vaccinated against HPV to avoid getting infected again.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Gaborone and 2 other locations) |
| Trial ID | NCT06436274 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of a single-dose nonavalent HPV vaccine in preventing HPV infection among women living with HIV who have previously received an HPV vaccination before their HIV diagnosis. Participants will be randomly assigned to receive either the HPV vaccine immediately or after a delay, with a control group receiving a meningococcal vaccine. The primary outcome is the vaccine efficacy against HPV types 16, 18, 31, 33, 45, 52, and 58. The study aims to provide critical evidence on the effectiveness of HPV vaccination in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 16 and older, living with HIV, who have received a prior HPV vaccination and are sexually active.
Not a fit: Patients with cervical abnormalities or allergies to vaccine components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of HPV-related diseases among women living with HIV.
How similar studies have performed: Previous studies have shown promising results for HPV vaccination in various populations, but this specific approach in women living with HIV is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Assigned female at birth 2. Age 16 years and above on the day of signing the informed consent form 3. Living with HIV with confirmed test results or clinic records 4. History of receiving a single dose of an HPV vaccine before HIV diagnosis 5. Self-reported sexually active in the last six months 6. Lives within the study area and willing to provide updated locator information over the course of the study 7. Does not have an autoimmune, degenerative, or genetic disease 8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV) 9. No other Investigator-determined factor would limit participation in the trial 10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study 11. The participant has a cervix Exclusion Criteria: 1. Anyone with cervical abnormality on examination 2. Anyone with an allergy to vaccine components or yeast
Where this trial is running
Gaborone and 2 other locations
- Botswana Harvard Health Partnershi — Gaborone, Botswana (Not_yet_recruiting)
- Ministry of Health and Center for Family Health Research — Kigali, Rwanda (Not_yet_recruiting)
- Wits RHI, University of the Witwatersrand — Johannesburg, Gauteng, South Africa (Recruiting)
Study contacts
- Principal investigator: Ruanne Barnabas, MBChB, MSc, DPhil — Mass General Brigham
- Study coordinator: Diane Kanjilal, FNP
- Email: IDCRU@mgh.harvard.edu
- Phone: 617-643-9958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.