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COMPLETED
NCT03284866
PHASE3

HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV

Sponsor: AIDS Malignancy Consortium

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

535

Start Date

2019-07-31

Completion Date

2025-08-05

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

OTHER

Saline

Given IM

Locations (6)

Moi University School of Medicine

Eldoret, Kenya

UNC Project Malawi

Lilongwe, Malawi

African Cancer Institute at Stellenbosch

Cape Town, South Africa

University of the Witwatersrand

Johannesburg, South Africa

Uganda Cancer Institute

Kampala, Uganda

University of Zimbabwe

Harare, Zimbabwe