Immune response to a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Immunosuppression; COVID-19 vaccination; Neurological - Multiple sclerosis; Infection - Other infectious diseases

• Registration Number: ACTRN12623001249640
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-30
• Study Start: 2023-12-01
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Ability to understand requirements of the study, provide written informed consent and attend follow-up
-Age 18+ years
-Diagnosis of relapsing-remitting MS (RRMS), primary progressive MS (PPMS) or secondary progressive MS (SPMS)
-Receiving ocrelizumab or natalizumab as primary treatment with the last dose received within 24 months of vaccine administration
-Have elected to receive a third COVID-19 vaccine dose with a Therapeutic Goods Administration (TGA) approved mRNA-platform vaccine

Exclusion Criteria

-Unable to provide written informed consent
-Acutely ill at the time of screening
-Is pregnant
-Known or suspected allergy or history of anaphylaxis to the vaccine or its excipients
-Has significant, uncontrolled disease or comorbidity (endocrine, cardiovascular, gastrointestinal, hepatic, renal, respiratory)
-Immunodeficiency (primary or secondary to infection e.g. HIV or cancer)
-Receiving systemic immunosuppressive agents including steroids - other than those required as per standard ocrelizumab or natalizumab treatment protocol

Study & Design

• Study Type: Observational
• Study Design: Not specified