Not Yet RecruitingPhase 3

Optimal Timing of Hepatitis B Vaccination After Transplants

China1,500 participantsStarted 2025-06-01

Plain-language 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 different immune reconstitution status.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Titer of hepatitis B surface antibodies (HBsAb).

Timeframe: One month after the completion of 3 doses of hepatitis B vaccine.

Trial details

NCT IDNCT06888479

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Xiaowen Gong

022-23608045 gongxiaowen@ihcams.ac.cn

View on ClinicalTrials.gov More Transplant-Related Disorder trials