Phase 1 safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by a gene delivery device

This study was designed to determine the safety and immunogenicity in volunteers of a DNA vaccine consisting of a plasmid encoding hepatitis B surface antigen delivered by the PowderJect XR1 gene delivery system into human skin. Seven healthy adult volunteers received two immunizations at one of thr...

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Bibliographic Details
Published in:Vaccine 1999-07, Vol.17 (22), p.2826-2829
Main Authors: Tacket, Carol O, Roy, Michael J, Widera, Georg, Swain, William F, Broome, Stephanie, Edelman, Robert
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies, Viral - blood
Biological and medical sciences
DNA vaccine
DNA, Viral - adverse effects
DNA, Viral - therapeutic use
Drug Delivery Systems - adverse effects
Epidemiology. Vaccinations
Fundamental and applied biological sciences. Psychology
General aspects
Hepatitis B - immunology
Hepatitis B - prevention & control
Hepatitis B Surface Antigens - genetics
Hepatitis B Surface Antigens - immunology
Hepatitis B vaccine
Hepatitis B Vaccines - adverse effects
Hepatitis B Vaccines - therapeutic use
Hepatitis B virus
Hepatitis B virus - genetics
Hepatitis B virus - immunology
Humans
Immunity, Mucosal - immunology
Infectious diseases
Injections, Intradermal - adverse effects
Medical sciences
Microbiology
Middle Aged
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies
Vaccines, DNA - adverse effects
Vaccines, DNA - therapeutic use
Virology
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Summary:This study was designed to determine the safety and immunogenicity in volunteers of a DNA vaccine consisting of a plasmid encoding hepatitis B surface antigen delivered by the PowderJect XR1 gene delivery system into human skin. Seven healthy adult volunteers received two immunizations at one of three forces of delivery on day 0 and 56. The vaccine was well tolerated. One of six seronegative volunteers developed high titers of persistent HBsAb after a single immunization. In retrospect, this volunteer may have had previous exposure to hepatitis B. Our study suggests that the hepatitis B DNA vaccine given by this gene delivery system may induce a booster response, but the vaccine at the extremely low DNA dose used (0.25 μg) did not induce primary immune responses.
ISSN:0264-410X
1873-2518
DOI:10.1016/S0264-410X(99)00094-8