PACTG P1047: PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT

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 P1047是一项在HIV感染儿童中进行的II期、随机、双盲、安慰剂对照的安全性和免疫原性研究，研究的疫苗是GARDASILTM（一种预防性四价HPV [6、11、16、18型] L1病毒样颗粒[VLP]疫苗）。 该疫苗已被证明有效，制造商已向FDA提交了用于9岁至成人健康人群的许可申请。 免疫功能低下的人，包括艾滋病毒感染者，尚未进行研究。本研究的主要目的是确定GARDASILTM在7-12岁HIV感染儿童中的安全性、耐受性和免疫原性。 次要目的是将GARDASILTM的安全性和免疫原性与接种时的免疫状态联系起来;进一步表征免疫应答的性质;并确定对第四剂（加强）疫苗的应答。该研究将在全国范围内招募120名> 7至< 12岁的儿童，并在当地招募13名儿童，以3：1的比例随机接受GARDASILTM或疫苗匹配的铝安慰剂。 90名儿童将接受GARDASILTM，30名儿童将在入组时以及第8周和第24周接受安慰剂，0.5 mL IM。 后续安全性评估和样本采集将延长至第96周。 受试者将在第96周揭盲。 接受GARDASILTM的患者将接受额外剂量的GARDASILTM。 接受安慰剂治疗的患者将开始一个完整的3剂GARDASIL？治疗方案。 研究设计要求所有受试者在开始招募后12个月内入组，以确保在第96周访视时对首例受试者揭盲前进行数据录入和清理。

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.