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  • Title: Tolerability and immune responses in humans to a PowderJect DNA vaccine for hepatitis B.
    Author: Swain WE, Heydenburg Fuller D, Wu MS, Barr LJ, Fuller JT, Culp J, Burkholder J, Dixon RM, Widera G, Vessey R, Roy MJ.
    Journal: Dev Biol (Basel); 2000; 104():115-9. PubMed ID: 11713809.
    Abstract:
    We are developing a DNA vaccine toward hepatitis-B virus (HBV) using PowderJect's proprietary needle-free technology to deliver DNA-coated gold particles directly into cells of the skin. Preclinical studies in animals showed that (i) microgram doses of the DNA vaccine were sufficient to immunize pigs and non-human primates to antibody levels comparable to those obtained with a commercial recombinant subunit vaccine; (ii) the DNA vaccine was effective in mouse strains that respond poorly to protein subunit vaccines; (iii) the vaccine induces robust cytotoxic T-cell responses, and (iv) the vaccine is non-toxic and well tolerated. Based on these findings, this DNA vaccine was evaluated for safety, tolerability, and the induction of immune responses in phase 1 clinical studies in healthy, hepatitis-naïve human volunteers. Preliminary results indicate that the vaccine is safe and well tolerated, and elicits both humoral and cellular immune responses in man.
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