A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults

Background: 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 anogenital disease compared to age-matched human immunodeficiency virus (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 cluster of differentiation 4 (CD4) and viral load parameters at entry. To determine whether HPV vaccination alters human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels. To investigate the impact of CD4 count and HIV-1 RNA levels on HPV vaccine immunogenicity. To characterize HPV deoxyribonucleic acid (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 reverse transcription (RT) polymerase chain reaction (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 500 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 prothrombin time (PT) or partial thromboplastin time (PTT) less than or equal to 1.5x upper limit of normal (ULN) (with the exception of patients with known clotting disorders or lupus anticoagulant); serum glutamic-pyruvic transaminase (SGPT)/Serum glutamic oxaloacetic transaminase (SGOT) \< 2/5x ULN, total bilirubin less than or equal to 1.5x 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, and 12 (+/- 2 weeks for each visit, and every 6 months (+/- 30 days) thereafter for 48 months total.