Optimal Timing of Hepatitis B Vaccination After Transplants

March 20, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: '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.
Biological: hepatitis B vaccine
Three doses of hepatitis B vaccine
Experimental: '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.
Biological: hepatitis B vaccine
Three doses of hepatitis B vaccine
Active Comparator: '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.
Biological: hepatitis B vaccine
Three doses of hepatitis B vaccine
Active Comparator: '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.
Biological: hepatitis B vaccine
Three doses of hepatitis B vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titer of hepatitis B surface antibodies (HBsAb).
Time Frame: 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.
One month after the completion of 3 doses of hepatitis B vaccine.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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