Hepatitis B DNA vaccine induces protective antibody responses in human non-responders to conventional vaccination.
A novel DNA vaccine against hepatitis B virus was administered intraepidermally by particle-mediated epidermal delivery (PMED) to 16 human subjects who demonstrated absent or non-sustainable responses to conventional hepatitis B vaccination. Eleven subjects received three doses of vaccine at 56-day intervals, and five subjects received only a single vaccination. Each dose of vaccine contained 4 microg of plasmid DNA encoding the hepatitis B surface antigen (HBsAg). The vaccine was safe and well tolerated. Remarkably, the DNA vaccine elicited antibody responses in 12 of the 16 subjects after a licensed subunit vaccine failed to induce a lasting response after >/=3 vaccinations. This study provides evidence in humans for protective immunogenicity of a particle-mediated DNA vaccine in subjects who have responded suboptimally to conventional vaccination.
Department of Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA.
Scott T
ST
Rottinghaus
Gregory A
GA
Poland
Robert M
RM
Jacobson
Lori J
LJ
Barr
Mike J
MJ
Roy
D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D005260:Female; D006510:Hepatitis B Antibodies / Q000032:analysis / Q000096:biosynthesis*; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D014611:Vaccination; D019444:Vaccines, DNA / Q000276:immunology
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D019444:Vaccines, DNA