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

NCT01292421 | Withdrawn DMC

• 2 other identifiers: I 124207NCI-2011-00064
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Maximum fold increase in anti-HBsAg titer levels relative to baseline levels

  Over 70 days

Secondary Outcomes (3)

• Absolute maximum response

  On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114

• Area under the curve

  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

  On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114

Study Arms (4)

Arm I

PLACEBO COMPARATOR

Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.

Other: placebo; Other: immunoenzyme technique

Arm II

EXPERIMENTAL

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; Other: placebo; Other: immunoenzyme technique

Arm III

EXPERIMENTAL

Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.

Biological: hepatitis B antigen peptide; Other: placebo; Other: immunoenzyme technique

Arm IV

EXPERIMENTAL

Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.

Biological: hepatitis B antigen peptide; Other: immunoenzyme technique

Interventions

hepatitis B antigen peptide BIOLOGICAL

Given PO

Also known as: HBsAg, peptide, hepatitis B antigen

Arm II; Arm III; Arm IV

placebo OTHER

Given orally (PO)

Also known as: PLCB

Arm I; Arm II; Arm III

immunoenzyme technique OTHER

Correlative studies

Also known as: immunoenzyme techniques

Arm I; Arm II; Arm III; Arm IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Interventions

Hepatitis B Surface Antigens; Immunoenzyme Techniques

Intervention Hierarchy (Ancestors)

Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Renuka Iyer

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: October 3, 2022

Record last verified: 2022-09