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 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 microg) did not induce primary immune responses.
Tacket
C O
CO
Center for Vaccine Development, Department of Medicine, University of Maryland School of Medicine, Baltimore 21201, USA.
Roy
M J
MJ
Widera
G
G
Swain
W F
WF
Broome
S
S
Edelman
R
R
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004279:DNA, Viral / Q000009:adverse effects / Q000627:therapeutic use; D016503:Drug Delivery Systems / Q000009:adverse effects; D006509:Hepatitis B / Q000276:immunology* / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000235:genetics* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000235:genetics* / Q000276:immunology*; D006801:Humans; D018928:Immunity, Mucosal / Q000276:immunology; D007271:Injections, Intradermal / Q000009:adverse effects; D008875:Middle Aged; D019444:Vaccines, DNA / Q000009:adverse effects / Q000627:therapeutic use*
D000914:Antibodies, Viral; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D019444:Vaccines, DNA