Protocol Number: 09-C-0024
Human papilloma virus (HPV) is one of the most common sexually transmitted diseases and a significant cause of cutaneous genital warts and anogenital cancer. Infection with high-risk, oncogenic HPV types, most commonly types 16 and 18, is associated with low and high-grade cervical cellular abnormalities that are precursors to invasive cervical cancer, as well as vulvar and anal cancer, while HPV types 6 and 11 are associated with genital warts. Persistence of HPV infection is more common in individuals with or at risk for chronic immunosuppression and HIV-infected individuals have a higher prevalence of HPV infection and HPV-associated anogential disease compared to age-matched HIV-negative controls. Study Objectives: To assess the safety and immunogenicity of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in HIV-infected preadolescents, adolescents and young adults 12-26 years of age. To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected and HIV negative age-matched controls. To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected patients receiving highly active antiretroviral therapy (HAART) and those not receiving HAART with similar CD4 and viral load parameters at entry. To determine whether HPV vaccination alters HIV-1 RNA levels. To investigate the impact of CD4 count and HIV-1 RNA levels on HPV vaccine immunogenicity. To characterize HPV DNA positivity in the study cohort populations through oral/buccal and anogenital sampling at baseline. To characterize HPV and HIV knowledge and risk and sexual behaviors in the study cohort populations. Eligibility: Individual Cohorts Cohort 1: HIV-positive, CD4 cell count greater than or equal to 350 cells/mm(3), HIV-1 RNA level by RT PCR less than or equal to 20,000 copies/ml, on stable HAART regimen for greater than or equal to 6 months. Cohort 2: HIV-infected, CD4 cell count greater than or equal to 350 cells/mm(3), HIV-1 RNA level by RT PCR less than or equal to 20,000 copies/ml, on no antiretroviral treatment. Cohort 3: healthy, HIV-negative controls All Cohorts Females and males age 12 to 26 years Patients must have a hemoglobin greater than or equal to 10.0 gm/dL, neutrophil count (ANC) greater than or equal to 1500/mm(3), platelet count greater than or equal to 75,000/mm(3) and PT or PTT less than or equal to 1.5 times ULN (with the exception of patients with known clotting disorders or lupus anticoagulant); SGPT/SGOT < 2/5 times ULN, total bilirubin less than or equal to 1.5 times ULN unless attributable to protease inhibitor therapy. Patients must test negative for hepatitis B virus and hepatitis C virus, unless the result is consistent with prior vaccination or prior infection with full recovery. No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry. Study Design: This is a non-randomized, prospective, phase I study of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine. The study includes 3 cohorts of pre-adolescents, adolescents and young adults 12-26 years of age as outlined under Eligibility Criteria. Each cohort will enroll 35 patients. All study subjects will receive three doses of HPV vaccine at 0, 2 and 6 months administered IM. Study participants will be monitored at months 0, 1, 2, 3, 6, 7, 9 and 12, and every 6 months thereafter for 48 months total.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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