PACTG P1047: PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT

PACTG P1047：四价的 II 期安全性和免疫原性研究

• 批准号: 7605148
• 负责人: Elizabeth Jane McFarland
• 金额: $ 4.08万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605148
• 关键词: Adult; Age-Years; Aluminum; Child; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Double-Blind Method; Enrollment; Ensure; Funding; Grant; HIV; Human Papillomavirus; Immune; Immune response; Immunocompromised Host; Institution; Manufacturer Name; Nature; Phase; Placebo Control; Placebos; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Source; Time; Treatment Protocols; United States Food and Drug Administration; United States National Institutes of Health; Vaccination; Vaccines; Virus-like particle; Visit; Week; aged; immunogenicity; prophylactic; response; sample collection

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 PACTG P1047是II期，随机，双盲，安慰剂控制的安全性和免疫原性研究，研究性疫苗GardasILTM（一种预防性四价HPV [类型6，11，16，16，18] L1病毒样病毒样[VLP] [VLP]疫苗），在HIV感染的儿童中。 该疫苗已经证明了功效，制造商已提交了一项申请，以供成人9岁的健康人使用，已提交给FDA。 尚未进行包括艾滋病毒在内的免疫功能低下的人的研究。这项研究的主要目标是确定GardasILTM在7-12岁的HIV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疫苗接种时的免疫状态联系起来；进一步表征免疫反应的性质；并确定对疫苗第四剂量（加强）剂量的反应。该研究将在全国范围内注册120名儿童> 7至<<12岁，在本地招收13名儿童，以随机分配以3：1的比例接受Gardasiltm或疫苗匹配的铝安慰剂。 有90名儿童将接受Gardasiltm，30名儿童将在入境时和8和24周时接受安慰剂，0.5毫升IM。 随后的安全评估和样本收集将延长到第96周。第96周将不盲目。那些接受Gardasiltm的人将获得额外的gardasiltm剂量。 那些接受安慰剂的人将开始使用Gardasiltm的完整三剂疗法。 研究设计要求在启动应计的12个月内招募所有受试者，以确保在第96周访问中解开第一个主题之前的数据输入和清理。