PACTG 1047: STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS VIRUS LIKE VACCINE IN HIV

PACTG 1047：HIV 四价人乳头瘤病毒样疫苗的研究

• 批准号: 7603589
• 负责人: ANN J MELVIN
• 金额: $ 0.07万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603589
• 关键词: Age-Years; Child; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Enrollment; Evaluable Disease; Funding; Gardasil; Grant; Human Papillomavirus; Institution; Muscle; Phase; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Sexually Transmitted Diseases; Site; Source; Stage Grouping; Staging; Study Subject; United States National Institutes of Health; Upper arm; Vaccines; Virus; Visit; Week; follow-up; 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 1047 is a Phase II, randomized, double-blind, placebo controlled multi-site study of the QHRP vaccine (GARDASIL). The QHRP vaccine is a vaccine against Human Papillomavirus (HPV), a sexually transmitted disease. A minimum of 120 evaluable HIV-infected children who are > 7 to < 12 years of age will be enrolled. Children will be randomized to one of two groups: Stage 1 vaccine recipients (90 children) will receive vaccine and Stage 1 placebo recipients (30 children) will receive placebo. Subjects will receive either the vaccine or matched placebo by IM (intramuscularly, or into a muscle in the arm) at entry and at Weeks 8 and 24. Subsequent safety assessment and sample collections will extend until Week 108. All subjects will be unblinded at their Week 96 visit, which means that the subjects and the study staff will know whether they have been receiving the vaccine or the placebo. Group 1 vaccine recipients will receive an additional dose of QHRP Vaccine at Week 96. Group II placebo recipients will receive QHRP Vaccine at Weeks 96, 104, and 120, with follow-up to Week 124. The total study duration for Stage I vaccine recipients will be 108 weeks. The total study duration for Stage 1 placebo recipients will be 124 weeks.

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。子项目和 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。 PACTG 1047 是一项针对 QHRP 疫苗 (GARDASIL) 的 II 期、随机、双盲、安慰剂对照多中心研究。 QHRP 疫苗是针对人乳头瘤病毒 (HPV)（一种性传播疾病）的疫苗。 将招募至少 120 名年龄 > 7 岁至 < 12 岁的可评估 HIV 感染儿童。 儿童将被随机分为两组：第一阶段疫苗接种者（90 名儿童）将接受疫苗，第一阶段安慰剂接受者（30 名儿童）将接受安慰剂。 受试者将在进入时以及第 8 周和第 24 周通过 IM（肌内注射，或注射到手臂肌肉中）接受疫苗或匹配的安慰剂。随后的安全评估和样本采集将持续到第 108 周。所有受试者在第 96 周访视时将不设盲，这意味着受试者和研究人员将知道他们是否接受了疫苗或安慰剂。 第 1 组疫苗接受者将在第 96 周接受额外剂量的 QHRP 疫苗。第 II 组安慰剂接受者将在第 96、104 和 120 周接受 QHRP 疫苗，并随访至第 124 周。I 期疫苗接受者的总研究持续时间将为 108 周。 第一阶段安慰剂接受者的总研究持续时间为 124 周。