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Clinical Trial
. 2005 Mar 1;102(9):3378-82.
doi: 10.1073/pnas.0409899102. Epub 2005 Feb 22.

Immunogenicity in humans of an edible vaccine for hepatitis B

Yasmin Thanavala  1 , Martin Mahoney, Sribani Pal, Adrienne Scott, Liz Richter, Nachimuthu Natarajan, Patti Goodwin, Charles J Arntzen, Hugh S Mason
Affiliations
Clinical Trial

Immunogenicity in humans of an edible vaccine for hepatitis B

Yasmin Thanavala et al. Proc Natl Acad Sci U S A. .

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.

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Figures

Fig. 1.
Fig. 1.
Time courses for changes in serum anti-HBs IgG in individual subjects. (A) Nine volunteers in group one consumed placebo potatoes on days 0, 14, and 28 (open arrowheads). None of the volunteers had any significant changes in their anti-HBs-specific titers during the study. (B) Ten of 16 volunteers who ate three doses (group three) of HBsAg-containing transgenic potatoes on days 0, 14, and 28 (closed arrowheads) showed marked increases in anti-HBs titers. Each line represents changes in an individual volunteer's antibody titer throughout the study period. (C) Nine of 17 volunteers (group two) who received transgenic potatoes on days 0 and 28 (closed arrowhead) and nontransgenic potatoes (open arrowhead) on day 14 showed marked increases in anti-HBs titers. Note the discontinuities in the ordinate axes in B and C and consequent breaks in the curves of higher-titer subjects.
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