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NCT06888479Not yet recruitingPhase 3

Optimal Timing of Hepatitis B Vaccination After Transplants

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

Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1500 (estimated)
First submitted
14 Jan 2025
Start date
1 Jun 2025
Primary completion date
1 Jun 2028
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Diseases
Hepatitis B
NCT number
NCT06888479

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1500
  • From 1 Jun 2025 to the primary completion date, 1 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Other

  • Multiple transplantations;
  • Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.

Who the study is looking for

  • 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.

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Hematology & Blood Diseases Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.