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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
hepatitis B vaccine
Biological/VaccineThree doses of hepatitis B vaccine
Treatment groups
1,500 Participants
are divided into 4 treatment groupsGroup A: 'Early Vaccination' (low-risk)Experimental treatment 1 intervention
Group B: 'Early Vaccination' (high-risk)Experimental treatment 1 intervention
Group C: 'Guideline' (low-risk)Active comparator 1 intervention
Group D: 'Guideline' (high-risk)Active comparator 1 intervention
Trial outcomes
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.
Time frame
One month after the completion of 3 doses of hepatitis B vaccine.Secondary outcomes
1
HBV infection
HBV-DNA or HBsAg are positive
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: