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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 HPV[6、11、16、18型]L1病毒样颗粒(VLP)(Gardasil)疫苗筛查时对HIV感染儿童的II期安全性和免疫原性研究 O层B：筛查时CD4%Nadir 15和15 O层C：筛查时CD4%Nadir 25和CD4%25 养生法： 第一阶段 肌肉注射(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在进入时以及在第8周和第24周。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本采集将延长至第108周。 第二阶段 在第96周的访问中，所有受试者将不会失明。 答：第I阶段疫苗接受者将在第96周额外接种一剂qHPV疫苗。 第一阶段的安慰剂接受者将在96周、104周和120周接种qHPV疫苗，并在124周进行随访。 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)和国家儿童健康与人类发育研究所(NICHD)通过儿科临床试验合作小组提供支持。这项试验的主要目标是确定qHPV疫苗的安全性和耐受性，并确定7至12岁艾滋病毒感染儿童接种qHPV疫苗后的血清转化率。 这项研究已接近应计。目前有七名受试者在CNMC学习。 2006/2007年本研究未发表论文(S)。 持续时间：疫苗接受者：总研究持续时间为108周。安慰剂接受者：总研究持续时间为124周。 安全：临时安全审查已完成，研究工作全面展开。 出版物：北美