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Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

NCT00604175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2021-11-04

Study results available
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Summary

Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.

Conditions

  • HIV Infections
  • Sexually Transmitted Diseases

Interventions

BIOLOGICAL

Quadrivalent HPV vaccine

Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Erna Milunka Kojic, MD · Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University

  • Susan Cu-Uvin, MD · Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-01-31
Completion
2012-11-30

Countries

  • United States
  • Brazil
  • Puerto Rico
  • South Africa

Study Locations

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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 NCT00604175 on ClinicalTrials.gov