Hepatitis BNCT03511794
Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant
An observational study of Hepatitis B, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 75 years
- Conditions the study is for
- Hepatitis B
- Type of treatment
- Vaccines
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 2 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who have received at least one dose of the hepatitis B vaccine
Who may be able to join
- 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.
Who cannot join
- 1. No post-vaccination titers available.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
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.
Read more
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...
Read the detailed description
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.
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B Reactivation, Allogenic Stem Cell Transplant, Natural History
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hep B vaccine | 1. Patient must have received at least one dose of the hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start13 Apr 2018
- Primary completion1 Jun 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard W Childs, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511794
- Sponsor's protocol ID
- 999918085
- Other IDs
- 18-H-N085
- Status last verified
- Feb 2022
- First submitted
- 27 Apr 2018
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03511794
- Acronym / sponsor ID
- 999918085
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B Reactivation, Allogenic Stem Cell Transplant, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hep B vaccine | – | –1. Patient must have received at least one dose of the hepatitis B vaccine |
Who may qualify
- Ages
- 4 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who have received at least one dose of the hepatitis B vaccine
Key inclusion criteria (2 listed)
Key exclusion criteria (1 listed)
- 1. No post-vaccination titers available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Childs, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.