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

NCT03284866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • AIDS-Related Human Papillomavirus Infection
  • High Grade Cervical Squamous Intraepithelial Neoplasia
  • HIV Infection

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

OTHER

Saline

Given IM

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Arkansas

    collaborator OTHER

  • AIDS and Cancer Specimen Resource

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of California, Los Angeles

    collaborator OTHER

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Carla Chibwesha · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2024-11-26
Completion
2025-08-05
FDA Drug
Yes

Countries

  • Kenya
  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284866 on ClinicalTrials.gov