Clinical trial NCT01292421: Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination
Official title: Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy, no Evidence of Disease
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
timeFrame: Over 70 days
Secondary outcomes:
measure: Absolute maximum response
timeFrame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
measure: Area under the curve
timeFrame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
measure: Proportion of two-fold responses in anti-HBsAg titer levels
timeFrame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Other outcomes:
Locations:
Study officials:
affiliation: Roswell Park Cancer Institute
name: Renuka Iyer
role: PRINCIPAL_INVESTIGATOR
References: