Trials / Completed
CompletedNCT03284866
HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions Among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 536 (actual)
- Sponsor
- AIDS Malignancy Consortium · Network
- Sex
- Female
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.
Detailed description
At screening, potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy to confirm the absence of cervical cancer. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later for the second dose of vaccine or placebo. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies before the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at weeks 26, 52, 78, and 104, and will have cervical cytology and colposcopy with biopsies at weeks 26, 52, and 104.
Conditions
- AIDS-Related Human Papillomavirus Infection
- High Grade Cervical Squamous Intraepithelial Neoplasia
- HIV Infection
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | Recombinant Human Papillomavirus Nonavalent Vaccine | Given IM |
| OTHER | Saline | Given IM |
Timeline
- Start date
- 2019-07-31
- Primary completion
- 2024-11-26
- Completion
- 2025-08-05
- First posted
- 2017-09-15
- Last updated
- 2026-01-28
Locations
6 sites across 5 countries: Kenya, Malawi, South Africa, Uganda, Zimbabwe
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03284866. Inclusion in this directory is not an endorsement.