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

Publication Type
Journal Article
Year of Publication
Catanzaro, Andrew T; Roederer, Mario; Koup, Richard A; Bailer, Robert T; Enama, Mary E; Nason, Martha C; Martin, Julie E; Rucker, Steve; Andrews, Charla A; Gomez, Phillip L; Mascola, John R; Nabel, Gary J; Graham, Barney S; VRC 007 Study Team
Date Published
2007 May 16
Adolescent; Adult; AIDS Vaccines; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Female; Gene Products, env; Gene Products, gag; Gene Products, nef; HIV Antibodies; HIV Infections; HIV-1; Humans; Immunity, Cellular; Male; nef Gene Products, Human Immunodeficiency Virus; Plasmids; Vaccines, Combined; Vaccines, DNA

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.