title: Immunogenicity in humans of an edible vaccine for hepatitis B.
abstract: A double-blind placebo-controlled clinical trial evaluated the immunogenicity of hepatitis B surface antigen (HBsAg) expressed in potatoes and delivered orally to previously vaccinated individuals. The potatoes accumulated HBsAg at approximately 8.5 microg/g of potato tuber, and doses of 100 g of tuber were administered by ingestion. The correlate of protection for hepatitis B virus, a nonenteric pathogen, is blood serum antibody titers against HBsAg. After volunteers ate uncooked potatoes, serum anti-HBsAg titers increased in 10 of 16 volunteers (62.5%) who ate three doses of potatoes; in 9 of 17 volunteers (52.9%) who ate two doses of transgenic potatoes; and in none of the volunteers who ate nontransgenic potatoes. These results were achieved without the coadministration of a mucosal adjuvant or the need for buffering stomach pH. We conclude that a plant-derived orally delivered vaccine for prevention of hepatitis B virus should be considered as a viable component of a global immunization program.
authors.affiliation: Department of Immunology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Thanavala
authors.forename: Martin
authors.initials: M
authors.lastname: Mahoney
authors.forename: Sribani
authors.initials: S
authors.lastname: Pal
authors.forename: Adrienne
authors.initials: A
authors.lastname: Scott
authors.forename: Liz
authors.initials: L
authors.lastname: Richter
authors.forename: Nachimuthu
authors.initials: N
authors.lastname: Natarajan
authors.forename: Patti
authors.initials: P
authors.lastname: Goodwin
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Arntzen
authors.forename: Hugh S
authors.initials: HS
authors.lastname: Mason
mesh_terms: D000284:Administration, Oral; D004311:Double-Blind Method; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000008:administration & dosage*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D030821:Plants, Genetically Modified
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines
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