PACTG P1059

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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。 研究假设这些候选疫苗在HIV-1感染的成人中是安全的，并且具有良好的耐受性。 亲本疫苗载体在健康和免疫功能低下的成人中是安全和免疫原性的。 在健康成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。这将是第一次在HIV-1感染者中进行疫苗研究。 16名接受抗逆转录病毒治疗的血浆HIV-1 RNA <100拷贝/ml的HIV-1感染成人（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），入组和第4周; rFPV-HIV env/gag（TBC-F357）和rFPV-HIV tat/rev/nef-RT（TBC-F349），第8周和第24周。 安全性评估将持续1小时、48小时和7天， 次免疫受试者将在末次免疫接种后随访48周。敏感试验 以表征正在进行的病毒血症的遗传性质和程度将在 免疫接种。将进行免疫原性探索性分析，尽管这些受试者中既存的HIV-1抗体和细胞应答可能会限制结果的解释。 P1059是一项多中心试验。 3例受试者将在当地入组。

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.