Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant
2 other identifiers
observational
52
1 country
1
Brief 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...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2018
CompletedFirst Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2022
CompletedFebruary 7, 2022
February 1, 2022
3.1 years
April 27, 2018
February 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
6 months
Study Arms (1)
hep B vaccine
1\. Patient must have received at least one dose of the hepatitis B vaccine
Eligibility Criteria
Patient who have received at least one dose of the hepatitis B vaccine
You may qualify if:
- 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.
You may not qualify if:
- \. No post-vaccination titers available.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W Childs, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2018
First Posted
April 30, 2018
Study Start
April 13, 2018
Primary Completion
June 1, 2021
Study Completion
February 2, 2022
Last Updated
February 7, 2022
Record last verified: 2022-02