Phase 1 safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by a gene delivery device.
Vaccine
; 17(22): 2826-9, 1999 Jul 16.
Article
em En
| MEDLINE
| ID: mdl-10438052
ABSTRACT
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.
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Base de dados:
MEDLINE
Assunto principal:
Vírus da Hepatite B
/
Vacinas contra Hepatite B
/
Vacinas de DNA
/
Hepatite B
/
Antígenos de Superfície da Hepatite B
Idioma:
En
Ano de publicação:
1999
Tipo de documento:
Article