Transplant-Related DisorderPhase 3NCT06888479
Optimal Timing of Hepatitis B Vaccination After Transplants
A Phase 3 study testing hepatitis B vaccine in people with Transplant-Related Disorder and Hepatitis B Virus Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transplant-Related Disorder, Hepatitis B Virus Infection, Vaccine Reaction
- What is being tested?
- hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be ≥ 16 years old;
- Patients receiving hematopoietic cell transplantation;
- Patients achieving complete molecular remission;
- Patients or their guardians have to sign an informed consent form before the start of the research procedure.
Who cannot join
- Multiple transplantations;
- Donors' HBV-DNA or HBsAg are positive;
- Patients' HBV-DNA or HBsAg are positive before transplantation or < 3 months after transplantation;
- Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
- Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study
The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.
- Being tested
- hepatitis B vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B vaccineBiological
Three doses of hepatitis B vaccine
| Study group | Role | What they receive |
|---|---|---|
| 'Early Vaccination' (low-risk) | Experimental | Patients with composite immune risk score (CIRS) ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation. Receives: Biological: hepatitis B vaccine |
| 'Early Vaccination' (high-risk) | Experimental | Patients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation. Receives: Biological: hepatitis B vaccine |
| 'Guideline' (low-risk) | Active comparator | Patients with CIRS ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation. Receives: Biological: hepatitis B vaccine |
| 'Guideline' (high-risk) | Active comparator | Patients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation. Receives: Biological: hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer of hepatitis B surface antibodies (HBsAb).
The investigators will compare the titer of HBsAb one month after the completion of 3 doses of hepatitis B vaccine in transplants with different timing of hepatitis B vaccination, different donor type and different immune reconstitution status.
Measured: One month after the completion of 3 doses of hepatitis B vaccine.
Secondary outcomes (1)
HBV infection
HBV-DNA or HBsAg are positive
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888479
- Sponsor's protocol ID
- IIT2024061
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06888479
- Acronym / sponsor ID
- IIT2024061
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 21 Mar 2025 (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.
The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 'Early Vaccination' (low-risk) | Experimental | Biological: hepatitis B vaccinePatients with composite immune risk score (CIRS) ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation. |
| 'Early Vaccination' (high-risk) | Experimental | Biological: hepatitis B vaccinePatients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation. |
| 'Guideline' (low-risk) | Active comparator | Biological: hepatitis B vaccinePatients with CIRS ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation. |
| 'Guideline' (high-risk) | Active comparator | Biological: hepatitis B vaccinePatients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be ≥ 16 years old;
- Patients receiving hematopoietic cell transplantation;
- Patients achieving complete molecular remission;
- Patients or their guardians have to sign an informed consent form before the start of the research procedure.
Key exclusion criteria (5 listed)
- Multiple transplantations;
- Donors' HBV-DNA or HBsAg are positive;
- Patients' HBV-DNA or HBsAg are positive before transplantation or < 3 months after transplantation;
- Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
- Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatitis B vaccineThree doses of hepatitis B vaccine | Biological | 'Early Vaccination' (high-risk), 'Early Vaccination' (low-risk), 'Guideline' (high-risk), 'Guideline' (low-risk) |
Primary outcome
Titer of hepatitis B surface antibodies (HBsAb).
Time frame: One month after the completion of 3 doses of hepatitis B vaccine.
The investigators will compare the titer of HBsAb one month after the completion of 3 doses of hepatitis B vaccine in transplants with different timing of hepatitis B vaccination, different donor type and different immune reconstitution status.
1 secondary outcome
HBV infection
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hepatitis B vaccine in people with Transplant-Related Disorder and Hepatitis B Virus Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Mar 2025. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Gong (022-23608045, gongxiaowen@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titer of hepatitis B surface antibodies (HBsAb). (time frame: One month after the completion of 3 doses of hepatitis B vaccine.). 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 21 Mar 2025.