Optimal Timing of Hepatitis B Vaccination After Transplants

Phase 3

Not yet recruiting

• Conditions: Transplant-Related Disorder; Hepatitis B Virus Infection; Vaccine Reaction
• Interventions: Biological: hepatitis B vaccine

• Registration Number: NCT06888479
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-06-01
• Primary Completion: 2028-06-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
'Early Vaccination' (low-risk)	hepatitis B vaccine	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.
'Early Vaccination' (high-risk)	hepatitis B vaccine	Patients 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)	hepatitis B vaccine	Patients 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)	hepatitis B vaccine	Patients with CIRS \> 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HBV infection	Through study completion, an average of 1 year	HBV-DNA or HBsAg are positive

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China