Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
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.
|Cervical Cancer Nonneoplastic Condition Precancerous Condition||Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Genetic: DNA analysis Genetic: polymerase chain reaction Other: cytology specimen collection procedure Procedure: colposcopic biopsy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||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|
- Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 [ Time Frame: 52 weeks from study entry ]Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
- Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count [ Time Frame: Screening/Week 0, Weeks 2, 10, 26, and 52. ]Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
- Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28 [ Time Frame: Week 28 ]Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
- Number of Patients With a Significant Increase in HIV Viral Load [ Time Frame: Screening/week 0, weeks, 2, 10, 26 and 52 ]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
- Number of Patients With Detectable Antibodies to HPV-6 [ Time Frame: 28 weeks ]Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
- Number of Patients With Detectable Antibodies to HPV-11 [ Time Frame: 28 weeks ]Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
- Number of Patients With Detectable Antibodies to HPV-18 [ Time Frame: 28 weeks ]Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
|Study Start Date:||August 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Gardasil Vaccination
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
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.
Other Name: HIV viral load test and HPV neutralization assays.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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667563
|Chennai, India, 600113|
|Study Chair:||Joel Palefsky, MD||University of California, San Francisco|
|Principal Investigator:||N. Kumarasamy, MD||YRG Care|