SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS

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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. This study's primary objective is to determine the safety, tolerability and immunogenicity of QHPV Vaccine in HIV infected Children. The secondary objective is to relate the safety and immunogenicity of QHPV Vaccine to the immune status at the time of vaccination; to further characterize the nature of the immune response; and to determine the response to a 4th (booster) dose of vaccine. The study will enroll 120 children at least 7 years of age to < 12 years of age to be randomized to receive QHPV Vaccine or vaccine-matched aluminum placebo in a 3:1 ratio. 90 children will receive QHPV Vaccine and 30 children will receive placebo, 0.5 mL IM at Entry and at 8 and 24 weeks. Subsequent safety assessments and sample collections will extend until Week 96. Subjects will be unblinded at Week 96. Those who received QHPV Vaccine will receive an additional dose of QHPV Vaccine. Prior to each dose of vaccine (or placebo), subjects must meet the criteria specified in section 6.4 (Criteria for Deferral of Vaccine/Placebo Doses, or Exclusion from Subsequent Doses of Vaccine/Placebo) of the sponsor's protocol. After unblinding at week 96, subjects who have been receiving placebo will undergo a reassessment of eligibility prior to vaccination as described in section 4.3 of the protocol. After each vaccination, subjects will be observed for at least 30 minutes for any immediate reaction, and, in particular, for evidence of allergic phenomena. (PACTG P1047 V1.0)