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Not yet recruiting NCT06888479

Optimal Timing of Hepatitis B Vaccination After Transplants

Phase III Interventional Transplant-Related Disorder Hepatitis B Virus Infection Vaccine Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hepatitis B vaccine.
Who it may be relevant to
Registry conditions: Transplant-Related Disorder, Hepatitis B Virus Infection, Vaccine Reaction. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Biological hepatitis B vaccine
    Three doses of hepatitis B vaccine

Primary outcome measures

  • Titer of hepatitis B surface antibodies (HBsAb). [Time frame: One month after the completion of 3 doses of hepatitis B vaccine.]
Secondary outcome measures (1)
  • HBV infection [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT06888479 · IIT2024061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗