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

NCT03511794 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2022-02-07

No results posted yet for this study

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...

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Richard W Childs, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
4 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2021-06-01
Completion
2022-02-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511794 on ClinicalTrials.gov