title: Tolerability and immune responses in humans to a PowderJect DNA vaccine for hepatitis B.
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.
authors.affiliation: PowderJect Vaccines, Inc., Madison, WI 53711, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Swain
authors.forename: D
authors.initials: D
authors.lastname: Heydenburg Fuller
authors.forename: M S
authors.initials: MS
authors.lastname: Wu
authors.forename: L J
authors.initials: LJ
authors.lastname: Barr
authors.forename: J T
authors.initials: JT
authors.lastname: Fuller
authors.forename: J
authors.initials: J
authors.lastname: Culp
authors.forename: J
authors.initials: J
authors.lastname: Burkholder
authors.forename: R M
authors.initials: RM
authors.lastname: Dixon
authors.forename: G
authors.initials: G
authors.lastname: Widera
authors.forename: R
authors.initials: R
authors.lastname: Vessey
authors.forename: M J
authors.initials: MJ
authors.lastname: Roy
mesh_terms: D000818:Animals; D019470:Biolistics / Q000295:instrumentation / Q000379:methods*; D004361:Drug Tolerance; D000882:Haplorhini; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D006801:Humans; D013552:Swine; D013602:T-Lymphocytes, Cytotoxic / Q000276:immunology; D019444:Vaccines, DNA / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D019444:Vaccines, DNA