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Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

NCT00667563 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

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

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

GENETIC

DNA analysis

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

GENETIC

polymerase chain reaction

Screening, week 36, and week 52.

OTHER

cytology specimen collection procedure

Screening, week 36, and week 52.

PROCEDURE

colposcopic biopsy

Screening, week 36, and week 52.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Joel Palefsky, MD · University of California, San Francisco

  • N. Kumarasamy, MD · YRG Care

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-11-30
Completion
2012-11-30
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT00667563 on ClinicalTrials.gov