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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043671
Receipt No. R000049869
Scientific Title Observational study on efficacy and safety of vaccines against the novel coronavirus disease (COVID-19) in hematopoietic stem cell transplantation (HSCT) patient.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/21

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Basic information
Public title Observational study on efficacy and safety of vaccines against the novel coronavirus disease (COVID-19) in hematopoietic stem cell transplantation (HSCT) patient.
Acronym FBMTG-COVID-19-VAC
Scientific Title Observational study on efficacy and safety of vaccines against the novel coronavirus disease (COVID-19) in hematopoietic stem cell transplantation (HSCT) patient.
Scientific Title:Acronym FBMTG-COVID-19-VAC
Region
Japan

Condition
Condition allo-SCT
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prospective assessment of the efficacy and safety of COVID-19 vaccines in HSCT patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluations of COVID-19 antibody titers before and after vaccination.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Nagafuji
Organization Kurume University School of Medicine
Division name Department of Medicine
Zip code 8300011
Address 67 Asahi machi,Kurume
TEL 0942-31-7852
Email fbmtg-office@umin.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Nagafuji
Organization Kurume University School of Medicine
Division name Department of Medicine
Zip code 8300011
Address 67 Asahi machi,Kurume
TEL 0942-31-7852
Homepage URL
Email fbmtg-office@umin.ac.jp

Sponsor
Institute Fukuoka Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization Fukuoka Blood and Marrow Transplantation Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kurume University School of Medicine IRB
Address 67 Asahi machi,Kurume
Tel 0942-65-3749
Email fbmtg-office@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 02 Month 03 Day
Date of IRB
2021 Year 03 Month 18 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Medical information (gender, underlying disease, medical history, etc.) of patients who have consented to participate in this study is collected. After obtaining a written consent, the registration form is faxed to the FBMTG data center. Blood sample (10 ml) is obtained to evaluate pre-vaccination endpoint. Complete blood count, IgG, T-cell percentage, B-cell percentage, CD4/CD8, and Elecsys Anti-SARS-CoV-2 S measurement (ECLIA) are outsourced to SRL, Inc. Side effects are evaluated after COVID-19 vaccinations. Questionnaire surveys are conducted after the first and second vaccinations. Between seven to 49 days after the second COVID-19 vaccination, blood sample (5ml) is collected for second measurement of Elecsys Anti-SARS-CoV-2 S. At this time, the two questionnaire surveys are collected, and faxed to the FBMG data center together with questionnaire 1. The efficacy of the COVID-19 vaccine is evaluated by comparing the antibody titers before and after vaccination and whether it meets the criterion for positivity of antibody. The frequency of side effects of the COVID-19 vaccine is also analyzed. Elecsys Anti-SARS-CoV-2 S is measured 1 year after vaccination, if desired by the attending physician or patient.

Management information
Registered date
2021 Year 03 Month 19 Day
Last modified on
2021 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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