UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044850 |
|---|---|
| Receipt number | R000051126 |
| Scientific Title | Analysis of immune response behavior and agents by vaccination with new coronavirus infections in patients with hematopoietic malignancies |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2025/01/14 14:30:33 |
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Basic information
Public title
Analysis of immune response behavior and agents by vaccination with new coronavirus infections in patients with hematopoietic malignancies
Acronym
Evaluation of efficacy of new coronavirus vaccination in patients with hematopoietic malignancies
Scientific Title
Analysis of immune response behavior and agents by vaccination with new coronavirus infections in patients with hematopoietic malignancies
Scientific Title:Acronym
Evaluation of efficacy of new coronavirus vaccination in patients with hematopoietic malignancies
Region
| Japan |
Condition
Condition
hematopoietic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effectiveness of the new coronavirus vaccine, focusing on the relationship with background factors of hematopoietic malignancies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of increase in SARS-CoV-2 antibody titer after COVID-19 vaccination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Inoculate COVID-19 vaccine twice
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients over 20 years old
2. Patients with multiple myeloma, chronic myelogenous leukemia, or after allogeneic hematopoietic stem cell transplantation
3. Patients who have consented to COVID-19 vaccination
4. Patients who have obtained consent for this study by signing the consent form
Key exclusion criteria
1. Patients who have difficulty or suffering from blood sampling and cannot tolerate multiple blood sampling
2. Patients with a history of vagal reflex
3. Patients who have already been vaccinated with COVID-19 vaccine
4. Patients with a history of SARS-CoV-2 infection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Nagata |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine III (Division of hematology)
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
+81-53-435-2267
yasu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Nagata |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine III (Division of hematology)
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
+81-53-435-2267
Homepage URL
yasu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel
+81-53-435-2680
rinri@hama-med.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 | 07 | Month | 13 | 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
65
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051126
