Efficacy and Safety of the BNT162b2, mRNA-1273, and ChAdOx1-S COVID-19 Vaccine in Patients who have received allogeneic hematopoietic stem cell transplantation for hematological diseases: An observational study.

Efficacy and Safety of the BNT162b2, mRNA-1273, and ChAdOx1-S COVID-19 Vaccine in Patients who have received allogeneic hematopoietic stem cell transplantation for hematological diseases: An observational study. - Allogeneic HSCT COVID19 vaccine study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046044

Enrollment

Registered

2021-11-11

Start date

2021-06-10

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

Patients who have received allogeneic hematopoietic stem cell transplantation for hematological diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have undergone allogeneic hematopoietic stem cell transplantation for hematological diseases for more than 3 months 2) Patients who are willing to receive the SARS-CoV-2 vaccination initiated by the Japanese government or local government. 3) Patients who have given written consent to participate in the study. If the patient is a minor (16 to 20 years old), the consent of both the patient and his/her guardian must be obtained.

Exclusion criteria

Exclusion criteria: 1) Those who are judged by the principal investigator or sub-investigator to be inappropriate for participation in the study. 2) Patients with a history of COVID-19 3) Patients who are unable to communicate with others

Design outcomes

Primary

Measure	Time frame
The primary endpoint was the rate of positivity of the SARS-CoV-2 IgG antibody.	—

Secondary

Measure	Time frame
Secondary endpoints will be SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, presence and content of post-vaccination adverse reactions, and GVHD.	—

Countries

Japan

Contacts

Public ContactMasashi Nishikubo

Kobe City Medical Center General Hospital Department of Hematology

masashi_nishikubo@kcho.jp078-302-4321

Outcome results