PACTG P1047 SAFETY AND IMMUNOGENICITY OF QUADRIVALENT HUMAN PAPILLOMA VIRUS

PACTG P1047 四价人乳头瘤病毒的安全性和免疫原性

• 批准号: 8167345
• 负责人: Steven L. Zeichner
• 金额: $ 0.73万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-20 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167345
• 关键词: Age; Child; Childhood; Clinical Trials; Clinical Trials Cooperative Group; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Gardasil; Grant; Human Papillomavirus; Human papillomavirus 6; Institution; Intramuscular; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Phase; Placebos; Publications; Regimen; Research; Research Personnel; Resources; Safety; Screening procedure; Source; Staging; United States National Institutes of Health; Vaccination; Vaccines; Virus-like particle; Visit; follow-up; immunogenicity; 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. Phase II Safety And Immunogenicity Study Of Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] L1 Virus-Like Particle (VLP) (Gardasil ) Vaccine In HIV-Infected Children 7 To 7 to 15 at screening o Stratum B: CD4% Nadir 15 and 15 at screening o Stratum C: CD4% Nadir 25 and CD4% 25 at screening Regimen: STAGE I Intramuscular (IM) Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] L1 VLP (QHPV) Vaccine or matched placebo at entry and at Weeks 8 and 24. Ninety children will receive vaccine and 30 children will receive placebo. Subsequent safety assessment and sample collections will extend until Week 108. STAGE II All subjects will be unblinded at their Week 96 visit. A. Stage I vaccine recipients will receive an additional dose of QHPV Vaccine at Week 96. B.Stage I placebo recipients will receive QHPV Vaccine at Weeks 96, 104, and 120, with follow-up to Week 124. Treatment P1047 is a multicenter clinical trial supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD) through the Pediatric Clinical Trials Cooperative Group. The primary objectives of this trial are to determine the safety and tolerability of QHPV Vaccine and to determine seroconversion after vaccination with QHPV Vaccine in HIV-infected children ages 7 to 12 years. This study is closed to accrual. Seven subjects are currently active on study at CNMC. No publication(s) arising from this study in 2006/2007. Duration: Vaccine recipients: Total study duration of 108 weeks. Placebo recipients: Total study duration of 124 weeks. Safety: Interim safety review completed and study fully accrued. Publications: NA

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。 II阶段的安全性和免疫原性研究的四价人乳头瘤病毒[6，11，16，18] L1病毒样颗粒（VLP）（Gardasil）疫苗在筛查时7至7的HIV感染儿童中 O层B：筛选时CD4％Nadir 15和15 O层C：CD4％NADIR 25和CD4％25筛选时 方案： 第一阶段 肌肉内（IM）四价人乳头瘤病毒[6、11、16、18] L1 VLP（QHPV）疫苗或匹配的安慰剂或第8周和24周时。有90名儿童将接种疫苗，30名儿童将接受安慰剂。 随后的安全评估和样品收集将延长至第108周。 第二阶段 在第96周的访问中，所有科目都将不盲目。 A. I期疫苗接收者将在第96周收到额外的QHPV疫苗。 B.阶段I安慰剂接收者将在第96、104和120周收到QHPV疫苗，并随访第124周。 治疗 P1047是由国家过敏和传染病研究所（NIAID）和美国国家儿童健康与人类发展研究所（NICHD）通过儿科临床合作组织支持的多中心临床试验。该试验的主要目标是确定QHPV疫苗的安全性和耐受性，并在7至12岁的HIV感染儿童中用QHPV疫苗接种后的血清转化。 这项研究对应计。目前在CNMC研究中有七个受试者活跃。 这项研究在2006/2007年没有出版。 持续时间：疫苗接收者：总研究持续时间为108周。安慰剂接受者：总研究时间为124周。 安全：临时安全审查完成并完全累积研究。 出版物：NA