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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
Weeks 0, 2, 10, 26, and 52.
Screening, week 36, and week 52.
YRG Care
Chennai, India
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Time frame: 52 weeks from study entry
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Time frame: Screening/Week 0, Weeks 2, 10, 26, and 52.
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Time frame: Week 28
Number of Patients With a Significant Increase in HIV Viral Load
Number of patients with a significant increase in HIV viral load defined as \> 1 log increase in HIV load from baseline on 2 consecutive occasions
Time frame: Screening/week 0, weeks, 2, 10, 26 and 52
Number of Patients With Detectable Antibodies to HPV-6
Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Time frame: 28 weeks
Number of Patients With Detectable Antibodies to HPV-11
Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Time frame: 28 weeks
Number of Patients With Detectable Antibodies to HPV-18
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
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Screening, week 36, and week 52.
Screening, week 36, and week 52.
Time frame: 28 weeks