Optimal Timing of Hepatitis B Vaccination After Transplants

Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06888479

Enrollment

1500

Registered

2025-03-21

Start date

2025-06-01

Completion date

2029-03-01

Last updated

2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus Infection, Transplant-Related Disorder, Vaccine Reaction

Brief 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.

Interventions

BIOLOGICALhepatitis B vaccine

Three doses of hepatitis B vaccine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
HBV infection	Through study completion, an average of 1 year	HBV-DNA or HBsAg are positive

Countries

China

Contacts

Primary ContactXiaowen Gong

gongxiaowen@ihcams.ac.cn022-23608045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026