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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01292421
First received: February 8, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy, no Evidence of Disease
 Biological: hepatitis B antigen peptide
Other: placebo
Other: immunoenzyme technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Maximum fold increase in anti-HBsAg titer levels relative to baseline levels [ Time Frame: Over 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute maximum response [ Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 ] [ Designated as safety issue: No ]
  • Area under the curve [ Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 0
Study Start Date: February 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.
 Other: placebo
Given orally (PO)
Other Name: PLCB
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques
Experimental: Arm II
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
 Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen
Other: placebo
Given orally (PO)
Other Name: PLCB
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques
Experimental: Arm III
Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
 Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen
Other: placebo
Given orally (PO)
Other Name: PLCB
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques
Experimental: Arm IV
Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.
 Biological: hepatitis B antigen peptide
Given PO
Other Names:
  • HBsAg
  • peptide, hepatitis B antigen
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292421

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Renuka Iyer Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01292421     History of Changes
Other Study ID Numbers: I 124207, NCI-2011-00064
Study First Received: February 8, 2011
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015