UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043671 |
|---|---|
| Receipt number | 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 | 2021/07/10 12:24:41 |
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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
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
fbmtg-office@umin.ac.jp
Sponsor or person
Institute
Fukuoka Blood and Marrow Transplantation Group
Institute
Department
Personal name
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
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
Open public recruiting
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 | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049869
