Optimal Timing of Hepatitis B Vaccination After Transplants
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- hepatitis B vaccine
Treatment groups
1,500 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov