Optimal Timing of Hepatitis B Vaccination After Transplants

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Transplant-Related Disorder Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Virus Infection Hepatitis, Viral, Human Infections Liver Diseases Vaccine Reaction Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hepatitis B vaccine

Biological

Three doses of hepatitis B vaccine

Primary outcomes

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.

Secondary outcomes

HBV infection

Time frame: Through study completion, an average of 1 year

HBV-DNA or HBsAg are positive

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaowen Gong

CONTACT

[email protected]

022-23608045

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: Mar 21, 2025
Registry last updated: Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting