Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.
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.
Catanzaro
Andrew T
AT
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Building 40, Bethesda, MD 20892-3017, USA.
Roederer
Mario
M
Koup
Richard A
RA
Bailer
Robert T
RT
Enama
Mary E
ME
Nason
Martha C
MC
Martin
Julie E
JE
Rucker
Steve
S
Andrews
Charla A
CA
Gomez
Phillip L
PL
Mascola
John R
JR
Nabel
Gary J
GJ
Graham
Barney S
BS
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D000293:Adolescent; D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D005260:Female; D015686:Gene Products, env / Q000276:immunology; D015683:Gene Products, gag / Q000276:immunology; D015693:Gene Products, nef / Q000276:immunology; D015483:HIV Antibodies / Q000096:biosynthesis / Q000276:immunology; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D008297:Male; D010957:Plasmids / Q000235:genetics / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D019444:Vaccines, DNA / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D054311:nef Gene Products, Human Immunodeficiency Virus
D016915:AIDS Vaccines; D015686:Gene Products, env; D015683:Gene Products, gag; D015693:Gene Products, nef; D015483:HIV Antibodies; D017778:Vaccines, Combined; D019444:Vaccines, DNA; D054311:nef Gene Products, Human Immunodeficiency Virus