title: Epidermal DNA vaccine for influenza is immunogenic in humans.
abstract: A phase I clinical trial was conducted to evaluate a monovalent influenza DNA vaccine containing the HA gene from A/Panama/2007/99 delivered by particle-mediated epidermal delivery (PMED). Three groups of 12 healthy adult subjects received a single dose on day 0 of either 1, 2 or 4 microg of DNA vaccine, delivered as 1, 2 or 4 PMED administrations. The PMED influenza DNA vaccine elicited serum hemagglutination-inhibition (HAI) antibody responses at all three dose levels, with the highest and most consistent responses in subjects vaccinated with the highest dose level. Antibody responses were greatest at the last time point tested, day 56. Treatment-related reactions were mild to moderate, and included skin reactions at the vaccine site. These results provide a preliminary indication of the safety and immunogenicity of a prototype epidermal DNA vaccine for influenza.
authors.affiliation: PowderJect Vaccines, Inc., 8551 Research Way, Middleton, WI 53562, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Drape
authors.forename: Michael D
authors.initials: MD
authors.lastname: Macklin
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Barr
authors.forename: Suzanne
authors.initials: S
authors.lastname: Jones
authors.forename: Joel R
authors.initials: JR
authors.lastname: Haynes
authors.forename: Hansi J
authors.initials: HJ
authors.lastname: Dean
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D004306:Dose-Response Relationship, Immunologic; D004817:Epidermis; D005260:Female; D006801:Humans; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D019444:Vaccines, DNA