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

September 30, 2022 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm I
Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.
Other: immunoenzyme technique
Correlative studies
Other Names:
  • immunoenzyme techniques
Other: placebo
Given orally (PO)
Other Names:
  • PLCB
Experimental: Arm II
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
Other: immunoenzyme technique
Correlative studies
Other Names:
  • immunoenzyme techniques
Other: placebo
Given orally (PO)
Other Names:
  • PLCB
Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen
Experimental: Arm III
Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
Other: immunoenzyme technique
Correlative studies
Other Names:
  • immunoenzyme techniques
Other: placebo
Given orally (PO)
Other Names:
  • PLCB
Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen
Experimental: Arm IV
Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.
Other: immunoenzyme technique
Correlative studies
Other Names:
  • immunoenzyme techniques
Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
Time Frame: Over 70 days
Over 70 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute maximum response
Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Area under the curve
Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Proportion of two-fold responses in anti-HBsAg titer levels
Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 124207
  • NCI-2011-00064 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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