title: Initial safety and immunogenicity studies of an oral recombinant adenohepatitis B vaccine.
abstract: Orally administered adenovirus may be a useful vaccine carrier of cloned antigens of other pathogens. A recombinant adenohepatitis vaccine Wy-Ad7HZ6-1, which expressed hepatitis B surface antigen and contained a large deletion in early region 3 (E3), was constructed and studied in humans. Volunteers received Wy-Ad7HZ6-1 (n = 3), adenovirus type 7 vaccine (n = 3) or placebo (n = 3). Recipients of Wy-Ad7HZ6-1 shed less vaccine virus in the stool for a shorter period and had a lower titre of anti-adenovirus type 7 antibodies than recipients of the adenovirus 7 vaccine. None of the three Wy-Ad7HZ6-1 vaccinees developed antibody to hepatitis B surface antigen after this one dose primary immunization regimen. The E3 region may be required for optimal enteric growth of adenovirus-vectored vaccines.
authors.affiliation: Department of Medicine, University of Maryland School of Medicine, Baltimore, 21201.
authors.forename: C O
authors.initials: CO
authors.lastname: Tacket
authors.forename: G
authors.initials: G
authors.lastname: Losonsky
authors.forename: M D
authors.initials: MD
authors.lastname: Lubeck
authors.forename: A R
authors.initials: AR
authors.lastname: Davis
authors.forename: S
authors.initials: S
authors.lastname: Mizutani
authors.forename: G
authors.initials: G
authors.lastname: Horwith
authors.forename: P
authors.initials: P
authors.lastname: Hung
authors.forename: R
authors.initials: R
authors.lastname: Edelman
authors.forename: M M
authors.initials: MM
authors.lastname: Levine
mesh_terms: D000260:Adenoviruses, Human / Q000276:immunology* / Q000302:isolation & purification; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D004341:Drug Evaluation; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D006514:Hepatitis B Surface Antigens; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines