PACTG 1047: STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS VIRUS LIKE VACCINE IN HIV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG 1047 is a Phase II, randomized, double-blind, placebo controlled multi-site study of the QHRP vaccine (GARDASIL). The QHRP vaccine is a vaccine against Human Papillomavirus (HPV), a sexually transmitted disease. A minimum of 120 evaluable HIV-infected children who are > 7 to < 12 years of age will be enrolled. Children will be randomized to one of two groups: Stage 1 vaccine recipients (90 children) will receive vaccine and Stage 1 placebo recipients (30 children) will receive placebo. Subjects will receive either the vaccine or matched placebo by IM (intramuscularly, or into a muscle in the arm) at entry and at Weeks 8 and 24. Subsequent safety assessment and sample collections will extend until Week 108. All subjects will be unblinded at their Week 96 visit, which means that the subjects and the study staff will know whether they have been receiving the vaccine or the placebo. Group 1 vaccine recipients will receive an additional dose of QHRP Vaccine at Week 96. Group II placebo recipients will receive QHRP Vaccine at Weeks 96, 104, and 120, with follow-up to Week 124. The total study duration for Stage I vaccine recipients will be 108 weeks. The total study duration for Stage 1 placebo recipients will be 124 weeks.