Phase I Clinical Evaluation of a Six-Plasmid Multiclade HIV-1 DNA Candidate Vaccine
Year of Publication
Catanzaro, AT; Roederer, M; Koup, RA; Bailer, RT; Enama, ME; Nason, MC; Martin, JE; Rucker, S; Andrews, CA; Gomez, PL; Mascola, JR; Nabel, GJ; Graham, BS; The VRC 007 Study Team
AIDS Vaccines; CD4-Positive T-Lymphocytes/immunology; CD8-Positive T-Lymphocytes/immunology; Gene Products; HIV Antibodies/biosynthesis/immunology; HIV-1/genetics/immunology; Immunity Cellular/immunology; Plasmids/genetics/immunology; Vaccines
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.