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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 PACTG 1047是一项QHRP疫苗（GARDASIL）的II期、随机、双盲、安慰剂对照多中心研究。 QHRP疫苗是一种针对人乳头瘤病毒（HPV）的疫苗，这是一种性传播疾病。 将招募至少120名可评估的7至12岁的HIV感染儿童。 儿童将被随机分为两组：第一阶段疫苗接种者（90名儿童）将接受疫苗，第一阶段安慰剂接种者（30名儿童）将接受安慰剂。 受试者将在入组时以及第8周和第24周通过IM（肌内注射或手臂肌肉注射）接受疫苗或匹配的安慰剂。 后续安全性评估和样本采集将延长至第108周。所有受试者将在第96周访视时揭盲，这意味着受试者和研究工作人员将知道他们是否接受了疫苗或安慰剂。 第1组疫苗接种者将在第96周接受额外剂量的QHRP疫苗。 第II组安慰剂接受者将在第96、104和120周接受QHRP疫苗，随访至第124周。 第I阶段疫苗接种者的总研究持续时间为108周。 第1阶段安慰剂接受者的总研究持续时间为124周。

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.