Optimal Timing of Hepatitis B Vaccination After Transplants

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Biological: hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06888479

IIT2024061

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

1,500 participants in 4 patient groups

'Early Vaccination' (low-risk)

Experimental group

Description:

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.

Treatment:

Biological: hepatitis B vaccine

'Early Vaccination' (high-risk)

Experimental group

Description:

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

Treatment:

Biological: hepatitis B vaccine

'Guideline' (low-risk)

Active Comparator group

Description:

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

Treatment:

Biological: hepatitis B vaccine

'Guideline' (high-risk)

Active Comparator group

Description:

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

Treatment:

Biological: hepatitis B vaccine