Optimal Timing of Hepatitis B Vaccination After Transplants

NCT06888479 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT2024061
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Titer of hepatitis B surface antibodies (HBsAb).

  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.

  One month after the completion of 3 doses of hepatitis B vaccine.

Secondary Outcomes (1)

• HBV infection

  Through study completion, an average of 1 year

Study Arms (4)

'Early Vaccination' (low-risk)

EXPERIMENTAL

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.

Biological: hepatitis B vaccine

'Early Vaccination' (high-risk)

EXPERIMENTAL

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

Biological: hepatitis B vaccine

'Guideline' (low-risk)

ACTIVE COMPARATOR

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

Biological: hepatitis B vaccine

'Guideline' (high-risk)

ACTIVE COMPARATOR

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

Biological: hepatitis B vaccine

Interventions

hepatitis B vaccine BIOLOGICAL

Three doses of hepatitis B vaccine

'Early Vaccination' (high-risk); 'Early Vaccination' (low-risk); 'Guideline' (high-risk); 'Guideline' (low-risk)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥ 16 years old;
• Patients receiving hematopoietic cell transplantation;
• Patients achieving complete molecular remission;
• Patients or their guardians have to sign an informed consent form before the start of the research procedure.

You may not qualify if:

• Multiple transplantations;
• Donors' HBV-DNA or HBsAg are positive;
• Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation;
• Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
• Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Xiaowen Gong

CONTACT

022-23608045; gongxiaowen@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: March 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)