Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
OBJECTIVES: I. To evaluate the safety, tolerability, and immunogenicity of orally delivered
HBsAg that is formulated as an expressed protein in transgenic potato tubers (HBV-EPV) at
different doses and schedules. OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Participants consume placebo HBV-EPV on days 0, 14, 28, and 56. ARM II:
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days
14 and 56. ARM III: Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56
and placebo HBV-EPV on day 14. ARM IV: Participants consume HBV-EPV expressing HBsAg on
days 0, 14, 28, and 56. After completion of study treatment, patients are followed up at
days 70, 84, 98, and 114.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
Over 70 days
Roswell Park Cancer Institute
United States: Food and Drug Administration