This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.
The aims are to evaluate the safety, immunogenicity, and social impact of this vaccine at both domestic and South African study sites.
Specific Aims are:' To evaluate the safety and tolerability of escalating doses (1 x 105, 1 x 106, 1 x 107 and 1 x 108 IU) of the alphavirus replicon HIV-1 subtype C gag vaccine (AVX101).' To evaluate the immunogenicity of the alphavirus replicon HIV-1 subtype C gag vaccine (AVX101) (escalating doses of 1 x 105, 1 x 106, 1 x 107 and 1 x 108 IU), as assessed by the following assays:' IFN- ELISpot' 51Chromium (51Cr) release (CTL) ' Lymphoproliferation assay' Intracellular cytokine staining (ICS)' Binding antibody by ELISA' To evaluate the development of anti-VEE vector immune responses, as assessed by a VRP neutralization assay.' To evaluate the social impacts of trial participation
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