Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 4 - 75 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | February 1, 2030 |
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...
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...
Based on current medical literature, the risk of hepatitis B reactivation is high after
allogenic stem cell transplant and can be a major problem in the post-transplant population,
leading to increased morbidity and mortality. Additionally, many people in the general
population and transplant population do not achieve immunity against hepatitis B with the
first vaccination series and may require repeat series.
Currently, it is unclear as to what percentage of post-transplant patients have a failed or
delayed immunity against hepatitis B and how many vaccine series it may take to eventually
achieve immunity. Previous data has eluded toward a seroconversion rate of 64% in children
and adults after vaccination with 20% of patients losing immunity by 5-years
post-vaccination. Additionally, the study found that 25% of patients did not achieve
protective titers following one vaccination series and of those that went on to be
revaccinated, 55% achieved seroconversion.
This is a single-center, retrospective analysis examining the effectiveness of the hepatitis
B vaccine posthematopoietic stem cell transplant and the impact of factors that may affect
seroconversion. Through this study, we hope to collect data on hepatitis B vaccination and
recommend potential protocol revisions if trends are found. We hypothesize that hepatitis B
immunity post-first vaccine series will occur in the majority of patients evaluated and that
patients failing to respond to the first vaccine series, will respond to subsequent
vaccination series.
The primary objective will be 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.
Secondary and exploratory objectives will include the evaluation of the percentages of
patients responding to vaccination on the 1st, 2nd, and 3rd attempt at the hepatitis B
vaccination series, the rate of reactivation of hepatitis B, and the analysis of factors
potentially impacting the response to vaccination.
allogenic stem cell transplant and can be a major problem in the post-transplant population,
leading to increased morbidity and mortality. Additionally, many people in the general
population and transplant population do not achieve immunity against hepatitis B with the
first vaccination series and may require repeat series.
Currently, it is unclear as to what percentage of post-transplant patients have a failed or
delayed immunity against hepatitis B and how many vaccine series it may take to eventually
achieve immunity. Previous data has eluded toward a seroconversion rate of 64% in children
and adults after vaccination with 20% of patients losing immunity by 5-years
post-vaccination. Additionally, the study found that 25% of patients did not achieve
protective titers following one vaccination series and of those that went on to be
revaccinated, 55% achieved seroconversion.
This is a single-center, retrospective analysis examining the effectiveness of the hepatitis
B vaccine posthematopoietic stem cell transplant and the impact of factors that may affect
seroconversion. Through this study, we hope to collect data on hepatitis B vaccination and
recommend potential protocol revisions if trends are found. We hypothesize that hepatitis B
immunity post-first vaccine series will occur in the majority of patients evaluated and that
patients failing to respond to the first vaccine series, will respond to subsequent
vaccination series.
The primary objective will be 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.
Secondary and exploratory objectives will include the evaluation of the percentages of
patients responding to vaccination on the 1st, 2nd, and 3rd attempt at the hepatitis B
vaccination series, the rate of reactivation of hepatitis B, and the analysis of factors
potentially impacting the response to vaccination.
- INCLUSION CRITERIA:
1. 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.
2. Post-vaccination titers must be available for patients included in the study.
EXCLUSION CRITERIA:
1. No post-vaccination titers available.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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