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Methods 49 healthy, vaccinia-naive volunteers were enrolled in a phase I randomized, double-blind, dose-escalation, route-comparison, placebo-controlled trial to assess the safety and immunogenicity of MVA-CMDR HIV-1 vaccine. The study was divided into Part A: low-dose 106/pfu ID versus 107 pfu/IM and Part B: high-dose 107 pfu/ID vs 108 pfu/IM. Vaccinations were given at months 0, 1 and 3 with an active:placebo ratio of 10:2. Chromium-release CTL, IFNγ Elispot, and polyfunctional flow cytometry (IL2/IFNγ/TNFα/MIP-1β/CD107a), were performed on all volunteers. Synthetic peptide pools and GLP-grade MVA were used to assess insert (Gag/Pol/Env) and vector immunogenicity respectively.

OA04-03. Characterization of cell-mediated immune responses generated by recombinant modified vaccinia Ankara (rMVA)-HIV-1 in a phase I vaccine trial