Phase I Clinical Evaluation of a Six-Plasmid Multiclade HIV-1 DNA Candidate Vaccine
05/2007
Journal Article
Authors:
Catanzaro, A.T.;
Roederer, M.;
Koup, R.A.;
Bailer, R.T.;
Enama, M.E.;
Nason, M.C.;
Martin, J.E.;
Rucker, S.;
Andrews, C.A.;
Gomez, P.L.;
, ;
Nabel, G.J.;
Graham, B.S.;
Team, T.V.R.C. 007 St
Secondary:
Vaccine
Volume:
25
Pagination:
4085-4092
URL:
http://www.ncbi.nlm.nih.gov/pubmed/17391815
Keywords:
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
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.
