CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 319 enrolled
Drug / intervention
Quadrivalent HPV vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00604175
NCT00604175Phase 2Completed
CompareCT.gov

A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 30, 2008·Updated Nov 4, 2021

In Brief

A Phase 2 clinical trial evaluating Quadrivalent HPV vaccine for HIV Infections and Sexually Transmitted Diseases. Completed, enrolled 319 participants across 61 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Sexually Transmitted Diseases
CountriesBrazil, Puerto Rico, South Africa, United States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.4 years ago

Interventions

Quadrivalent HPV vaccinebiological

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