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: 7951109
• 负责人: Steven L. Zeichner
• 金额: $ 1.11万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951109
• 关键词: Age; Child; Childhood; Clinical Research; 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; Research; Research Personnel; Resources; Safety; Screening procedure; Source; Staging; Treatment Protocols; 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

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。子项目和 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。 四价人乳头瘤病毒[6、11、16、18型] L1病毒样颗粒（VLP）（Gardasil）疫苗在筛选时7 - 7 - 15岁的HIV感染儿童中的II期安全性和免疫原性研究 O 层B：CD 4%最低点 筛选时15和15 O C层：筛选时CD4%最低点25和CD4% 25 方案： 一阶段 入组时以及第8周和第24周时，肌内注射（IM）四价人乳头瘤病毒[6、11、16、18型] L1 VLP（QHPV）疫苗或匹配的安慰剂。 90名儿童将接受疫苗，30名儿童将接受安慰剂。 后续安全性评估和样本采集将延长至第108周。 第二阶段 所有受试者将在第96周访视时揭盲。 A. I期疫苗接种者将在第96周接受额外剂量的QHPV疫苗。 B.第I阶段安慰剂接受者将在第96、104和120周接受QHPV疫苗，随访至第124周。 治疗 P1047是一项多中心临床试验，由国家过敏和传染病研究所（NIAID）和国家儿童健康和人类发育研究所（NICHD）通过儿科临床试验合作组支持。本试验的主要目的是确定QHPV疫苗的安全性和耐受性，并确定7至12岁HIV感染儿童接种QHPV疫苗后的血清转换。 本研究已停止招募。目前有7名受试者正在CNMC进行研究。 2006/2007年本研究未发表任何文献。 持续时间：疫苗接种者：研究总持续时间为108周。安慰剂接受者：总研究持续时间为124周。 安全性：完成中期安全性审查，研究完全累积。 出版物：NA