4:25AM Inovio Pharma completes PENNVAX-B HIV vaccine Phase I Study, demonstrates best-in-class T-Cell immune responses (INO) 0.71 : Co announces it has achieved best-in-class immune responses in a Phase I clinical study of PENNVAX. Of the 48 total volunteers, eight subjects received a placebo, 10 subjects received a 3 mg dose of Inovio's SynCon PENNVAX-B vaccine, and 30 subjects received a 3 mg dose of PENNVAX-B along with 1 mg of GENEVAX(TM)IL-12 DNA. All volunteers received vaccine or placebo administered via intramuscular injection with electroporation at months 0, 1, and 3. The T-cell immune responses were detected using a validated flow cytometry-based intracellular cytokine staining assay at the HVTN core immunology laboratory at the Fred Hutchinson Cancer Research Center (Seattle, WA). These data indicate that antigen-specific T-cell responses were generated by the vaccine in a majority of subjects. Overall, either CD4+ or CD8+ or both T-cell responses were observed against at least one of the vaccine antigens in 83.3% (30 of 36) of evaluated subjects after three vaccinations using electroporation. The response rate increased to 88.9% (24 of 27) of evaluated subjects after three vaccinations with electroporation plus the IL-12 cytokine gene adjuvant. The investigators in this study concluded that PENNVAX-B + IL-12 plasmid delivered via electroporation led to frequencies and magnitudes of cellular immune responses equal to or greater than those reported from current vector-based HIV vaccines such as adenovirus or traditional DNA vaccination without electroporation. Further trials delivering an HIV DNA vaccine using electroporation with or without IL-12 as a vaccine strategy are merited.
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