Optimal Timing of Hepatitis B Vaccination After Transplants

NCT ID: NCT06888479

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2029-03-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

'Early Vaccination' (low-risk)

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.

Group Type: EXPERIMENTAL

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Three doses of hepatitis B vaccine

'Early Vaccination' (high-risk)

Patients with CIRS \> 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation.

Group Type: EXPERIMENTAL

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Three doses of hepatitis B vaccine

'Guideline' (low-risk)

Patients with CIRS ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.

Group Type: ACTIVE_COMPARATOR

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Three doses of hepatitis B vaccine

'Guideline' (high-risk)

Patients with CIRS \> 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.

Group Type: ACTIVE_COMPARATOR

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Three doses of hepatitis B vaccine

Interventions

hepatitis B vaccine

Three doses of hepatitis B vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Xiaowen Gong

Role: CONTACT

gongxiaowen@ihcams.ac.cn

022-23608045

Other Identifiers

IIT2024061

Identifier Type: -

Identifier Source: org_study_id