Observational study on efficacy and safety of vaccines against the novel coronavirus disease (COVID-19) in hematopoietic stem cell transplantation (HSCT) patient.

Observational study on efficacy and safety of vaccines against the novel coronavirus disease (COVID-19) in hematopoietic stem cell transplantation (HSCT) patient. - FBMTG-COVID-19-VAC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043671

Enrollment

1000

Registered

2021-04-01

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allo-SCT

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.16 years old and over. 2.The underlying diseases are acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, aplasticanemia, and malignant lymphoma. 3.More than 6 months after the most recent hematopoietic stem cell transplantation. 4.Scheduled to receive COVID-19 vaccine. 5.Blood samples can be obtained before vaccination and at 7 to 49 days after the second vaccination.

Exclusion criteria

Exclusion criteria: 1.Grade III-IV acute GVHD at the time of registration. 2.Anti-CD20 antibody therapy within 6 months. 3.CAR-T cell therapy within 6 months with B cell depletion. 4.Anti-thymocyte globulin (ATG) or alemtuzumab therapy within 6 months. 5.Judged to be inappropriate by the principal investigator and the research coordinator.

Design outcomes

Primary

Measure	Time frame
Evaluations of COVID-19 antibody titers before and after vaccination.	—

Countries

Japan

Contacts

Public ContactKoji Nagafuji

Kurume University School of Medicine Department of Medicine

fbmtg-office@umin.ac.jp0942-31-7852

Outcome results