CompletedNot Applicable

Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant

United States52 participantsStarted 2018-04-13

Plain-language summary

Background: Stem cell transplants (SCTs) are important in treating many diseases. There are two main types of transplants. Autologous stem cells come from the person getting the cells. Allogeneic stem cells come from another person. The risk of hepatitis B virus (HBV) is high after allogeneic SCT. Even if a person receives the HBV vaccine after transplant, he or she may not really be immune to HBV. The person may become immune only after repeated series of the vaccine. Researchers need to learn more about the HBV vaccine in people after transplant so it can be most effective. Objective: To assess the rate of achieved HBV immunity for people who had an SCT who did not become immune with the first vaccine series and require 2 or more series. Eligibility: People who have had at least 1 dose of the HBV vaccine and were enrolled in these protocols: 99-H-0050, 10-H-0154, and 08-H-0046 Design: Participants will be screened in the other protocols. Participants data and medical charts will be reviewed. Data from up to 350 participants who had transplants before March 2016 will be reviewed. Participants data will be collected: Demographic data Type of transplant Type of donor Clinical information about the transplant...

Who can participate

Age range

4 Years – 75 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient must have received at least one dose of the hepatitis B vaccine and been enrolled in the following NHLBI protocols: 99-H-0050, 10-H-0154, and 08-H-0046.
. Post-vaccination titers must be available for patients included in the study.

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

to assess the rate of achieved immunity for those patients that do not achieve immunity with the first vaccine series and require two or more vaccine series

Timeframe: 6 months

Trial details

NCT IDNCT03511794

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2021-06-01

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