Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination (NCT01292421) | Clinical Trial Compass
WithdrawnNot Applicable
Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination
0Started 2013-02
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels