UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049478 |
|---|---|
| Receipt number | R000054698 |
| Scientific Title | Immune Response to SARS-CoV-2 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs |
| Date of disclosure of the study information | 2022/11/11 |
| Last modified on | 2023/10/30 15:54:07 |
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Basic information
Public title
Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs
Acronym
Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs
Scientific Title
Immune Response to SARS-CoV-2 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs
Scientific Title:Acronym
Immune Response to SARS-CoV-2 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs
Region
| Japan |
Condition
Condition
Multiple Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the effect of disease modifying drugs (DMDs) for multiple sclerosis (MS) on the efficacy of the SARS-CoV-2 virus mRNA vaccine. We will also determine whether switching the Sphingosine receptor modulator (FTY or BAF312), which has been reported to attenuate antibody production by mRNA vaccines, to natalizumab (NTZ) or dimethyl fumarate (DMF) will restore the immune system to elicit adequate antibody production following SARS-CoV-2 mRNA vaccination.
Adult patients with other neurological diseases except immunological diseases who visited the Department of Neurology and Stroke, Osaka University Hospital (Other neurological disease: OND) will also be included in the comparison.
Basic objectives2
Others
Basic objectives -Others
Antibody titer against SARS-CoV-2 virus mRNA vaccine
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Antibody titer against SARS-CoV-2 spike protein (RBD)
Key secondary outcomes
FACS analysis of peripheral blood PBMCs
Gene expression analysis of PBMCs by RNA-seq
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with MS aged 20 years or older who visited Osaka University Hospital will be eligible.
MS patients who meet the following specific criteria will be included.
<eligibility criteria>
Meet the 2017 McDonald's diagnostic criteria.
Has a history of treatment with DMD.
Has received or will receive at least one mRNA vaccination against SARS-CoV-2 at the time of consent.
Age at the time of consent: 20 years or older.
Has given or will give written consent to participate in the study.
Key exclusion criteria
Has been infected with SARS-CoV-2 virus up to 3 months after the second mRNA vaccination against SARS-CoV-2.
Known allergy or contraindication to any vaccine component.
Has received treatment with another vaccine within 4 weeks of the first SARS-CoV-2 mRNA vaccine.
Participating in another clinical trial.
Has used steroids within 3 months of the first SARS-CoV-2 mRNA vaccine and within 3 months of the second dose.
Received intravenous or subcutaneous immunoglobulin (IVIG/SCIG) within 3 months after the first or second dose of SARS-CoV-2 mRNA vaccine.
Other cases in which the attending physician deems it inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsusada |
| Middle name | |
| Last name | Okuno |
Organization
Osaka University
Division name
Department of Neurology, Osaka University Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka 565-0871
TEL
06-6879-3571
okuno@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsusada |
| Middle name | |
| Last name | Okuno |
Organization
Osaka University
Division name
Department of Neurology, Osaka University Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka 565-0871
TEL
06-6879-3571
Homepage URL
okuno@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Biogen Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Ethics Review Committee
Address
4F, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
大阪大学大学院医学系研究科神経内科学講座（大阪府）／
Department of Neurology, Osaka University Graduate School of Medicine（Osaka）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a case-control study. Using blood samples (about 10 ml) after SARS-CoV-2 mRNA vaccination of MS patients attending Osaka University Hospital, we will conduct (1) antibody titer against SARS-CoV-2 S protein, (2) FACS analysis of peripheral blood PBMC, (3) expressed gene analysis by RNA-seq of PBMC, and The efficacy of SARS-CoV-2 mRNA vaccine in each therapeutic agent will be investigated. Existing blood specimens will be used, but additional blood samples will be collected when blood tests are required in the practice.
Handling of Personal Information, etc. (including the method of anonymization, if any) Anonymization
Data containing personal information of research subjects to be collected in this study will be anonymized by deleting names, addresses, and other personal information when information is collected from electronic medical records, assigning identification codes for research purposes, and creating a correspondence table. The correspondence table will be kept strictly by the personal information manager at each research institute. Only anonymized information will be handled for the transfer of information between research institutions.
Safety control measures
Physical safety control (data management PCs are kept under lock and key in a storage room in the laboratory, recording media are prohibited from being taken out, theft and leakage are prevented, personal data are deleted, and equipment and electronic media are disposed of), technical safety control (access control to data management PCs, unauthorized access from the outside is prevented through unauthorized software measures), and organizational safety control. (Access control to data management PCs, prevention of unauthorized external access, etc.), organizational safety control (limitation of handling of personal information and limitation of authority to principal investigators and research assistants), and personnel safety control (periodic training).
Management information
Registered date
| 2022 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054698
