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

Healthy, no Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01292421
• Other study ID #: I 124207
• Secondary ID: NCI-2011-00064
• Status: Withdrawn
• Phase: N/A
• Start date: February 2013

Study information

• Verified date: September 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All Roswell Park Cancer Institute (RPCI) staff, faculty, and students, who are in good health
• Participants confirmation of history of primary immunization series with recombinant hepatitis B (HB) vaccine (last dose at least one year prior to screening anti-HBs level assessment)
• Current anti-HBs levels less than or equal to 115 mIU/mL
• Major organ functions within acceptable medical limits as determined in routine clinical laboratory screening tests
• Expected availability for the duration of the study period
• If female, then documentation that the subject is not pregnant by an acceptable laboratory test and that the subject is using an adequate birth control method to prevent pregnancy for at least 3 months following the last immunization in the study
• Human immunodeficiency virus (HIV) antibody negative
• Ability to provide written informed consent
• Supervisor approval

Exclusion Criteria:

• Known history of allergy or hypersensitivity to potato, potato components or potato products
• Known history of allergy to hepatitis B vaccine in any form or to components of hepatitis B vaccine
• Pregnancy or breast feeding
• Current anti-HBS levels greater than 115 mIU/mL
• Known immunodeficiency, cancer, or use of immunosuppressive medication including cancer chemotherapy and systemic steroids (excluding intermittent use of topical steroids)
• Participation in another investigational study within 30 days of enrollment in this study
• Known and currently active gastrointestinal disease including any of the following:

peptic ulcer disease, gastroesophageal reflux, inflammatory bowel disease, diverticulitis, or pancreatitis

• Use of prescription medication or over the counter H2 blockers or proton pump inhibitors (PPIs) for any of the above diseases regularly and within 1 month of enrollment
• Diagnosis of insulin-dependent diabetes or multiple sclerosis
• Significant laboratory abnormality which suggests dysfunction of hematological, renal, or hepatic systems
• Known history of hepatitis B infection in the past
• Temporary exclusion for mild upper respiratory illness, gastrointestinal illness, or other febrile episode that is expected and documented to resolve

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease
• Hepatitis B

Intervention

Biological:
• hepatitis B antigen peptide
Given PO

Other:
• placebo
Given orally (PO)
• immunoenzyme technique
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum fold increase in anti-HBsAg titer levels relative to baseline levels		Over 70 days
Secondary	Absolute maximum response		On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Secondary	Area under the curve		On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Secondary	Proportion of two-fold responses in anti-HBsAg titer levels		On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114