PACTG P1047: PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT

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 P1047是一项针对HIV感染儿童的研究疫苗GARDASILTM(一种预防性四价HPV[6、11、16、18型L1病毒样颗粒[VLP]疫苗)的第二阶段随机、双盲、安慰剂对照安全性和免疫原性研究。这种疫苗已经证明了有效性，制造商已经向FDA提交了一份用于9岁到成年人的健康人群的Liscensen申请。对免疫功能低下的人，包括艾滋病毒携带者，还没有进行研究。这项研究的主要目的是确定GARDASILTM在7-12岁艾滋病毒感染儿童中的安全性、耐受性和免疫原性。次要目标是将GARDASILTM的安全性和免疫原性与接种疫苗时的免疫状态联系起来；进一步确定免疫反应的性质；以及确定对第四剂(加强)疫苗的反应。这项研究将在全国范围内招募120名7岁至12岁的儿童和13名当地儿童，随机接受GARDASILTM或与疫苗匹配的铝安慰剂，比例为3：1。90名儿童将接受GARDASILTM治疗，30名儿童将在入院时、8周和24周接受安慰剂、0.5毫升肌注。随后的安全评估和样本采集将延长至第96周。受试者将在第96周解除失明。那些接受GARDASILTM的人将获得额外剂量的GARDASILTM。那些接受安慰剂的人将开始完整的GARDASILTM三剂方案。研究设计要求所有受试者在开始应计后12个月内登记，以确保在第96周访问时第一个受试者解盲之前输入和清理数据。

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 P1047 is a Phase II, randomized, double-blind, placebo-controlled safety and immunogenicity study of an investigational vaccine, GARDASILTM (a prophylactic Quadrivalent HPV [Types 6, 11, 16, 18] L1 Virus-Like Particle [VLP] vaccine), in HIV-infected children. This vaccine has demonstrated efficacy and the manufacturer has submitted an application for liscensure for use in healthy people aged 9yr to adult has been submitted to the FDA. Studies in immunocompromised people, including those with HIV, have not yet been performed. The primary objectives of this study are to determine the safety, tolerability and immunogenicity of GARDASILTM in HIV-infected children aged 7-12 years. The secondary objectives are to relate the safety and immunogenicity of GARDASILTM 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 fourth (booster) dose of vaccine. The study will enroll 120 children > 7 to < 12 years of age nationally and 13 children locally to be randomized to receive GARDASILTM or vaccine-matched aluminum placebo in a 3:1 ratio. Ninety children will receive GARDASILTM 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 GARDASILTM will receive an additional dose of GARDASILTM. Those who received placebo will begin a full 3-dose regimen of GARDASILTM. The study design requires that all subjects be enrolled within 12 months of initiating accrual, in order to ensure data entry and clean-up prior to unblinding the first subject at the Week 96 visit.