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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 四价人乳头瘤病毒 [6、11、16、18 型] L1 病毒样颗粒 (VLP)（加卫苗）疫苗在 7 至 7 至 15 岁 HIV 感染儿童筛查中的 II 期安全性和免疫原性研究 o B 层：筛选时 CD4% 最低点 15 和 15 o C 层：筛选时 CD4% Nadir 25 和 CD4% 25 治疗方案： 第一阶段 在入组时以及第 8 周和第 24 周时肌内 (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。 随后的安全评估和样本采集将延续至第 108 周。 第二阶段 所有受试者在第 96 周访视时将被揭盲。 答：第一阶段疫苗接种者将在第 96 周接受额外剂量的 QHPV 疫苗。 B. 第一阶段安慰剂接受者将在第 96、104 和 120 周接受 QHPV 疫苗，并跟进至第 124 周。 治疗 P1047是一项多中心临床试验，由美国国家过敏和传染病研究所（NIAID）和国家儿童健康与人类发展研究所（NICHD）通过儿科临床试验合作组支持。该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 疫苗后的血清转化情况。 这项研究已停止计提。目前有七名受试者正在 CNMC 积极学习。 2006/2007 年本研究没有发表任何出版物。 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：中期安全审查已完成，研究已全部完成。 出版物：不适用