Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Condition: Cervical Cancer; Nonneoplastic Condition; Precancerous Condition
MeSH terms: Uterine Cervical Neoplasms; Precancerous Conditions; Disease
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; DNA analysis; polymerase chain reaction; cytology specimen collection procedure; colposcopic biopsy
Intervention type(s): Biological; Genetic; Genetic; Other; Procedure
Intervention description(s): 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.; Screening, week 36, and week 52.; Screening, week 36, and week 52.
Other intervention name(s): HIV viral load test and HPV neutralization assays.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: human papilloma virus infection; cervical cancer; cervical intraepithelial neoplasia; HIV infection