PACTG P1059

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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.