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Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.

Research paper by Andrew T AT Catanzaro, Mario M Roederer, Richard A RA Koup, Robert T RT Bailer, Mary E ME Enama, Martha C MC Nason, Julie E JE Martin, Steve S Rucker, Charla A CA Andrews, Phillip L PL Gomez, John R JR Mascola, Gary J GJ Nabel, Barney S BS Graham,

Indexed on: 30 Mar '07Published on: 30 Mar '07Published in: Vaccine



Abstract

Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4(+) [13/14 (93%)] and CD8(+) [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.