SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS

四价人乳头病毒的安全性和免疫原性研究

• 批准号: 7606296
• 负责人: Stephen I. Pelton
• 金额: $ 0.43万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606296
• 关键词: Age-Years; Allergic; Aluminum; Child; Computer Retrieval of Information on Scientific Projects Database; Dose; Eligibility Determination; Enrollment; Exclusion; Funding; Grant; HIV; Human Papillomavirus; Immune; Immune response; Institution; Nature; Placebos; Protocols documentation; Randomized; Reaction; Research; Research Personnel; Resources; Safety; Source; Specific qualifier value; Time; United States National Institutes of Health; Vaccination; Vaccines; Week; immunogenicity; response; 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. This study's primary objective is to determine the safety, tolerability and immunogenicity of QHPV Vaccine in HIV infected Children. The secondary objective is to relate the safety and immunogenicity of QHPV Vaccine to the immune status at the time of vaccination; to further characterize the nature of the immune response; and to determine the response to a 4th (booster) dose of vaccine. The study will enroll 120 children at least 7 years of age to < 12 years of age to be randomized to receive QHPV Vaccine or vaccine-matched aluminum placebo in a 3:1 ratio. 90 children will receive QHPV Vaccine and 30 children will receive placebo, 0.5 mL IM at Entry and at 8 and 24 weeks. Subsequent safety assessments and sample collections will extend until Week 96. Subjects will be unblinded at Week 96. Those who received QHPV Vaccine will receive an additional dose of QHPV Vaccine. Prior to each dose of vaccine (or placebo), subjects must meet the criteria specified in section 6.4 (Criteria for Deferral of Vaccine/Placebo Doses, or Exclusion from Subsequent Doses of Vaccine/Placebo) of the sponsor's protocol. After unblinding at week 96, subjects who have been receiving placebo will undergo a reassessment of eligibility prior to vaccination as described in section 4.3 of the protocol. After each vaccination, subjects will be observed for at least 30 minutes for any immediate reaction, and, in particular, for evidence of allergic phenomena. (PACTG P1047 V1.0)

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。 本研究的主要目的是确定 QHPV 疫苗在 HIV 感染儿童中的安全性、耐受性和免疫原性。第二个目标是将 QHPV 疫苗的安全性和免疫原性与接种时的免疫状态联系起来；进一步表征免疫反应的性质；并确定对第四剂（加强剂）疫苗的反应。 该研究将招募 120 名年龄至少 7 岁至 < 12 岁的儿童，按照 3:1 的比例随机接受 QHPV 疫苗或疫苗匹配的铝安慰剂。 90 名儿童将接受 QHPV 疫苗，30 名儿童将在入组时以及第 8 周和第 24 周时接受安慰剂、0.5 mL IM。随后的安全评估和样本采集将持续到第 96 周。受试者将在第 96 周揭盲。那些接受 QHPV 疫苗的人将接受额外剂量的 QHPV 疫苗。 在每次接种疫苗（或安慰剂）之前，受试者必须符合申办者方案第 6.4 节（推迟疫苗/安慰剂剂量的标准，或排除后续剂量的疫苗/安慰剂的标准）中指定的标准。第 96 周揭盲后，接受安慰剂的受试者将在接种疫苗之前接受资格重新评估，如方案第 4.3 节所述。 每次疫苗接种后，将观察受试者至少 30 分钟是否有任何立即反应，特别是过敏现象的证据。 (PACTG P1047 V1.0)