UMIN-ICDS Clinical Trial

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

Multiple Sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

okuno@neurol.med.osaka-u.ac.jp

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

Email

okuno@neurol.med.osaka-u.ac.jp

Institute

Osaka University
Department of Neurology, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Biogen Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2022

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

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/icdr_e/ctr_view.cgi?recptno=R000054698