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Vaccine ; 24(37-39): 6216-24, 2006 Sep 11.
Article in English | MEDLINE | ID: mdl-16824652

ABSTRACT

BACKGROUND: CKS257 (Salmonella typhimurium SL1344 DeltaphoP/phoQDelta aroA Deltaasd DeltastrA/strB pSB2131) is a live oral vaccine vector expressing HIV Gag. METHODS: HIV Gag was expressed as a fusion protein of a Salmonella Type III secretion system protein SopE, from a balanced lethal asd-based plasmid. Eighteen healthy adults were given single escalating oral doses of 5 x 10(6) to 1 x 10(10)CFU of CKS257 and were monitored for clinical events, shedding and immune responses. RESULTS: Adverse events were mild except at the highest dose. Volunteers shed the organism an average of 5.1 days (range 0-13 days). Eighty-three percent (15/18) of subjects had a mucosal immune response to Salmonella LPS and flagella by IgA ELISPOT assay. Seventy-two percent (13/18) of subjects seroconverted to Salmonella antigens. No volunteer had a response to recombinant Gag as measured by serology, IgA ELISPOT, or immediate ex vivo gamma-interferon ELISPOT response to Gag peptide pools. Two volunteers responded to Gag peptides by IL-2 ELISPOT, and 4 of 10 volunteers receiving >or=5 x 10(8)CFU had a response to HIV peptides in a cultured gamma-interferon ELISPOT assay. CONCLUSIONS: Although immunogenicity of the HIV antigen needs augmentation, the attenuated Salmonella strain proved to be an excellent platform for vaccine development.


Subject(s)
AIDS Vaccines/immunology , Bacterial Proteins/immunology , Gene Products, gag/immunology , HIV-1/immunology , Salmonella Vaccines/immunology , Salmonella typhi/immunology , AIDS Vaccines/adverse effects , AIDS Vaccines/genetics , Adolescent , Adult , Amino Acid Sequence , Animals , Bacterial Proteins/adverse effects , Bacterial Proteins/genetics , Dose-Response Relationship, Immunologic , Gene Products, gag/genetics , HIV Core Protein p24/immunology , HIV Infections/immunology , HIV Infections/prevention & control , HIV-1/genetics , Humans , Mice , Mice, Inbred BALB C , Middle Aged , Molecular Sequence Data , Recombinant Fusion Proteins/adverse effects , Recombinant Fusion Proteins/genetics , Recombinant Fusion Proteins/immunology , Salmonella Vaccines/adverse effects , Salmonella Vaccines/genetics , Salmonella typhi/genetics , Salmonella typhi/physiology , U937 Cells , Vaccines, Attenuated/adverse effects , Vaccines, Attenuated/genetics , Vaccines, Attenuated/immunology
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