Healthy, no Evidence of DiseaseNCT01292421
Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination
A study testing hepatitis B antigen peptide and immunoenzyme technique in people with Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- hepatitis B antigen peptide and immunoenzyme technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Human immunodeficiency virus (HIV) antibody negative
- Ability to provide written informed consent
- Supervisor approval
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- hepatitis B antigen peptide, placebo, immunoenzyme technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B antigen peptideBiological
Also called HBsAg, peptide, hepatitis B antigen
Given PO
placeboOther
Also called PLCB
Given orally (PO)
immunoenzyme techniqueOther
Also called immunoenzyme techniques
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Placebo comparator | Participants consume placebo HBV-EPV on days 0, 14, 28, and 56. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: hepatitis B antigen peptide; Other: immunoenzyme technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
Measured: Over 70 days
Secondary outcomes (3)
Absolute maximum response
Measured: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Area under the curve
Measured: 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
Measured: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renuka Iyer, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292421
- Sponsor's protocol ID
- I 124207
- Other IDs
- NCI-2011-00064
- Status last verified
- Sep 2022
- First submitted
- 8 Feb 2011
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01292421
- Acronym / sponsor ID
- I 124207
- Conditions
- Healthy, no Evidence of Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Placebo comparator | Other: placebo, Other: immunoenzyme techniqueParticipants consume placebo HBV-EPV on days 0, 14, 28, and 56. |
| Arm II | Experimental | Biological: hepatitis B antigen peptide, Other: placebo, Other: immunoenzyme techniqueParticipants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56. |
| Arm III | Experimental | Biological: hepatitis B antigen peptide, Other: placebo, Other: immunoenzyme techniqueParticipants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14. |
| Arm IV | Experimental | Biological: hepatitis B antigen peptide, Other: immunoenzyme techniqueParticipants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatitis B antigen peptideAlso: HBsAg, peptide, hepatitis B antigenGiven PO | Biological | Arm II, Arm III, Arm IV |
| placeboAlso: PLCBGiven orally (PO) | Other | Arm I, Arm II, Arm III |
| immunoenzyme techniqueAlso: immunoenzyme techniquesCorrelative studies | Other | Arm I, Arm II, Arm III, Arm IV |
Primary outcome
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
Time frame: Over 70 days
3 secondary outcomes
Absolute maximum response
Time frame: 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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renuka Iyer principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing hepatitis B antigen peptide and immunoenzyme technique in people with Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels (time frame: Over 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.