Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.
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;
VRC 007 Study Team.
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Building 40, Bethesda, MD 20892-3017, USA.
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.
PMID: 17391815 [PubMed - indexed for MEDLINE]