Journal
VACCINE
Volume 21, Issue 31, Pages 4604-4608Publisher
ELSEVIER SCI LTD
DOI: 10.1016/S0264-410X(03)00447-X
Keywords
DNA vaccines; vaccination; hepatitis B; particle-mediated delivery; immunogenicity
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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 mug 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 greater than or equal to3 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. (C) 2003 Elsevier Ltd. All rights reserved.
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