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
- 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
- Determine the proportion of these patients who respond serologically to the HPV vaccine
and the kinetics of their response.
- Determine the prevalence and incidence of cervical intraepithelial neoplasia in these
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Safety, in terms of grade 3 or 4 adverse events attributed to the vaccine, according to NCI CTCAE v3.0
52 weeks from study entry
Joel Palefsky, MD
University of California, San Francisco
United States: Federal Government