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Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs

Immune Response to SARS-CoV-2 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs - Immune Response to SARS-CoV-2 Vaccine in Multiple Sclerosis Patients on Disease-Modifying Drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049478
Enrollment
50
Registered
2022-11-11
Start date
2022-02-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Interventions

None listed

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Antibody titer against SARS-CoV-2 spike protein (RBD)

Secondary

MeasureTime frame
FACS analysis of peripheral blood PBMCs Gene expression analysis of PBMCs by RNA-seq

Countries

Japan

Contacts

Public ContactTatsusada Okuno

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

okuno@neurol.med.osaka-u.ac.jp06-6879-3571

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026