PACTG P1059

PACTG P1059

• 批准号: 7605135
• 负责人: Elizabeth Jane McFarland
• 金额: $ 1.77万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605135
• 关键词: Adult; Antibodies; Biological Assay; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Fowlpox vector; Funding; Gagging; Genetic; Grant; HIV-1; HIV-1 vaccine; Hour; Immunization; Immunocompromised Host; Individual; Institution; Label; Modified Vaccinia Virus Ankara; Nature; Personal Satisfaction; Phase; Plasma; RNA; Research; Research Personnel; Resources; Safety; Site; Source; United States National Institutes of Health; Vaccines; Viremia; Week; antiretroviral therapy; day; immunogenic; immunogenicity; response; vector vaccine

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 P1059 is a Phase I, open-label, study to determine the safety and tolerability of modified vaccinia Ankara (MVA) and fowlpox vector (FPV) HIV-1 vaccines. The study hypothesis is that these candidate vaccines will be safe and well tolerated in HIV-1 infected adults with virologic suppression. The parental vaccine vectors have been safe and immunogenic in healthy and immunocompromised adults. Preliminary results from a study of these vaccines in healthy adults indicate that vaccines have been well tolerated. This will be the first study of the vaccines in HIV-1 infected individuals. Sixteen HIV-1-infected adults (18 to <25 years) with plasma HIV-1 RNA <100 copies/ml on antiretroviral therapy will receive the following four immunizations: rMVA-HIV env/gag (TBC-M358) and rMVA-HIV tat/rev/nef- RT (TBC-M335) at entry and week 4; rFPV-HIV env/gag (TBC-F357) and rFPV-HIV tat/rev/nef-RT (TBC-F349) at week 8 and 24. Safety will be assessed for one hour, 48 hours, and 7 days post- immunization. Subjects will be followed for 48 weeks after the last immunization. Sensitive assays to characterize the genetic nature and extent of ongoing viremia will be preformed before and after immunizations. Exploratory analyses of immunogenicity will be conducted athough pre-existing antibody and cellular responses to HIV-1 in these subjects may limit interpretation of the results. P1059 is a multi-site trial. Three subjects will be enrolled locally.

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。 PACTG P1059是一项第一阶段的开放标签研究，旨在确定改良的安卡拉牛痘(MVA)和鸡痘载体(FPV)HIV-1疫苗的安全性和耐受性。研究假设是，这些候选疫苗在病毒学抑制的HIV-1感染成年人中将是安全和耐受性良好的。亲本疫苗载体在健康和免疫低下的成年人中是安全的和免疫原性的。在健康成年人中对这些疫苗进行的研究的初步结果表明，疫苗具有良好的耐受性。这将是第一次对HIV-1感染者接种疫苗的研究。16名HIV-1感染成人(18岁至25岁)在接受抗逆转录病毒治疗时，血浆HIV-1RNA和100拷贝/毫升将接受以下四种免疫接种：rMVA-HIV env/gag(TBC-M358)和rMVA-HIV TAT/rev/nef-RT(TBC-M335)；rFPV-HIV env/gag(TBC-F357)和rFPV-HIV Tat/rev/nef-RT(TBC-F349)。安全性将在免疫后1小时、48小时和7天内进行评估。在最后一次免疫后，受试者将被跟踪48周。将在免疫前后进行敏感的分析，以确定持续病毒血症的遗传性质和程度。将对免疫原性进行探索性分析，尽管这些受试者中先前存在的HIV-1抗体和细胞反应可能会限制对结果的解释。P1059是一项多点试验。三个科目将在当地招生。