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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 PACTG 1047是QHRP疫苗(Gardasil)的二期、随机、双盲、安慰剂对照的多点研究。QHRP疫苗是一种针对人乳头瘤病毒(HPV)的疫苗，HPV是一种性传播疾病。至少有120名7岁至12岁的可评估的艾滋病毒感染儿童将被登记。儿童将被随机分为两组：第一阶段疫苗接受者(90名儿童)将接受疫苗接种，第一阶段安慰剂接受者(30名儿童)将接受安慰剂。受试者将在入院时、第8周和第24周通过肌注(肌肉内或手臂肌肉内)接受疫苗或匹配的安慰剂。随后的安全评估和样本采集将延长至第108周。所有受试者将在第96周的访问中解盲，这意味着受试者和研究人员将知道他们是否一直在接受疫苗或安慰剂。第1组疫苗接受者将在第96周接受额外剂量的QHRP疫苗接种。第二组安慰剂接受者将在96周、104周和120周接受QHRP疫苗接种，并在124周进行随访。第一阶段疫苗接受者的总研究时间为108周。第一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.