Optimal Timing of Hepatitis B Vaccination After Transplants

NCT06888479 · tracked via the Priya Life Science China tracker

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Phase

Phase 3

Started

2025-06-01

Last updated

2025-03-21

Condition(s) studied

Transplant-Related DisorderHepatitis B Virus InfectionVaccine Reaction

Investigational drug(s) / intervention(s)

hepatitis B vaccine

hepatitis B vaccine: Three doses of hepatitis B vaccine

Study 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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients must be ≥ 16 years old; 2. Patients receiving hematopoietic cell transplantation; 3. Patients achieving complete molecular remission; 4. Patients or their guardians have to sign an informed consent form before the start of the research procedure. Exclusion Criteria: 1. Multiple transplantations; 2. Donors' HBV-DNA or HBsAg are positive; 3. Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation; 4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions; 5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.

Primary outcome measure(s)

Titer of hepatitis B surface antibodies (HBsAb). — 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.

Trial sites (1)

Facility	City	Region	Status
Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06888479 on ClinicalTrials.gov ↗ ← All trials in China