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。 PACTG 1047是QHRP疫苗（Gardasil）的II期，随机，双盲，安慰剂控制的多站点研究。 QHRP疫苗是一种针对人乳头瘤病毒（HPV）的疫苗，这是一种性传播疾病。 至少有120名可评估的艾滋病毒感染儿童年龄在7至12岁以上。 儿童将被随机分为两组之一：1期疫苗接收者（90名儿童）将接种疫苗，而第1期安慰剂接受者（30名儿童）将接受安慰剂。 受试者将在入口和第8周和第24周收到IM（肌肉内或肌肉中的肌肉）接种疫苗或匹配的安慰剂。随后的安全评估和样本收集将延伸到第108周。所有受试者在第96周的访问中都不会盲目访问，这意味着他们和研究人员是否会知道他们是否已经收到了疫苗或接种疫苗。 第1组疫苗接收者将在第96周收到额外剂量的QHRP疫苗。第II组安慰剂接受者将在第96、104和120周接收QHRP疫苗，并进行第124周的随访。I期疫苗接受者的总研究持续时间为108周。 1阶段安慰剂接受者的总研究持续时间为124周。