NCT01292421

Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination

Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg vaccine therapy in healthy participants who have undergone previous vaccination.

Detailed description

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.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
BIOLOGICAL	hepatitis B antigen peptide	Given PO
OTHER	placebo	Given orally (PO)
OTHER	immunoenzyme technique	Correlative studies

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• First posted: 2011-02-09
• Last updated: 2022-10-03