CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 150 enrolled
Drug / intervention
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine +4 morebiological
Likely dose
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine 0.5 mLfrom 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/NCT00667563
NCT00667563Phase 1Completed
CompareCT.gov

A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India

AIDS Malignancy Consortium·interventional·Posted Apr 28, 2008·Updated Mar 19, 2024

In Brief

A Phase 1 clinical trial evaluating quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis, and 3 other interventions for Cervical Cancer and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer. PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Nonneoplastic Condition, Precancerous Condition
CountriesIndia
CollaboratorsNational Cancer Institute (NCI), The Emmes Company, LLC

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.2 years ago

Interventions

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccinebiological

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysisgenetic

Weeks 0, 2, 10, 26, and 52.

polymerase chain reactiongenetic

Screening, week 36, and week 52.

cytology specimen collection procedureother

Screening, week 36, and week 52.

colposcopic biopsyprocedure

Screening, week 36, and week 52.