NCT00667563

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Assess the safety of the Gardasil® quadrivalent human papillomavirus (HPV) (types 6, 11, 16,18) virus-like-particle vaccine with vs without prior exposure to one or more of the HPV types in the vaccine in HIV-positive women in Chennai, India. * Determine the effect of the vaccine on HIV viral load and CD4+/CD8+ levels in these patients. * Determine the proportion of these patients who respond serologically to the HPV vaccine and the kinetics of their response. Secondary * Determine the prevalence and incidence of cervical intraepithelial neoplasia in these patients. * Determine the spectrum of cervical HPV types in these patients at baseline, 9 months, and 1 year after vaccination. OUTLINE: This is a multicenter study. Patients receive quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and once in weeks 8 and 24. Patients undergo cervical cell, buccal cell, and blood sample collection at baseline and periodically after vaccination for immunologic and virologic studies. Cervical cytology specimens are examined by polymerase chain reaction to detect HPV 6, 11, 16, or 18 DNA, as well as 35 other HPV types. Blood samples are analyzed for CD4+/CD8+ cell count, plasma HIV-1 RNA levels, and serum HPV antibody titers for HPV types 6, 11, 16, and 18. Some plasma samples will be stored for future HPV pseudovirion neutralization assays. After completion of study therapy, patients are followed periodically for up to 12 months.

Conditions

• Cervical Cancer
• Nonneoplastic Condition
• Precancerous Condition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-04-28
• Last updated: 2024-03-19
• Results posted: 2014-04-11

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study