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.

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 中心，不一定是研究者的机构。 PACTG P1059 是一项 I 期开放标签研究，旨在确定改良安卡拉牛痘 (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 感染成人中是安全的且具有良好的耐受性。 亲代疫苗载体对于健康和免疫功能低下的成年人来说是安全的且具有免疫原性。 对健康成年人进行的这些疫苗研究的初步结果表明，疫苗具有良好的耐受性。这将是针对 HIV-1 感染者的疫苗的首次研究。 接受抗逆转录病毒治疗且血浆 HIV-1 RNA <100 拷贝/ml 的 16 名 HIV-1 感染成年人（18 至 <25 岁）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) 在进入时和第 4 周；第 8 周和第 24 周时的 rFPV-HIV env/gag (TBC-F357) 和 rFPV-HIV tat/rev/nef-RT (TBC-F349)。将在免疫后 1 小时、48 小时和 7 天评估安全性。受试者将在最后一次免疫后跟踪 48 周。将在免疫接种之前和之后进行敏感测定，以表征持续病毒血症的遗传性质和程度。尽管这些受试者中预先存在的抗体和细胞对 HIV-1 的反应可能会限制结果的解释，但仍将进行免疫原性的探索性分析。 P1059 是一个多站点试验。 三个科目将在当地注册。