None listed
Conditions
Brief summary
Evaluate immunity provided to people with multiple sclerosis (pwMS) receiving B cell depleting therapy with ocrelizumab by a third mRNA-platform COVID-19 vaccine dose. Immunity was evaluated by comparison with pwMS receiving treatment the non-depleting drug natalizumab and through comparison against a correlate of real-world protection against infection. Peripheral blood immune cells were analysed in order to describe how the altered immune system in pwMS receiving ocrelizumab is associated with vaccine response, and to identify potential predictors of immune response to stratify poor responders for antiviral prophylaxis.
Interventions
Trial is non-interventional - participants will be recruited who are receiving ongoing treatment for multiple sclerosis of ocrelizumab monoclonal antibody by intravenous infusion (600 mg, 6 monthly) as part of routine care. Participants are eligible if they have received an infusion within 12 months of the 3rd COVID-19 vaccine dose (see inclusion criteria).
Participants will receive a COVID-19 mRNA vaccine dose (BNT162b2 Pfizer or mRNA1273 Moderna) as third dose as part of routine care, i.e. a
Trial is non-interventional - participants will be recruited who are receiving ongoing treatment for multiple sclerosis of ocrelizumab monoclonal antibody by intravenous infusion (600 mg, 6 monthly) as part of routine care. Participants are eligible if they have received an infusion within 12 months of the 3rd COVID-19 vaccine dose (see inclusion criteria). Participants will receive a COVID-19 mRNA vaccine dose (BNT162b2 Pfizer or mRNA1273 Moderna) as third dose as part of routine care, i.e. a single dose of 30ug/0.3mL or 50ug/0.25mL. Time interval since administration of second dose is not a determinant of eligibility. Participants will be required to provide a peripheral blood sample immediately prior to vaccination, and a second peripheral blood sample four weeks after vaccination (requiring a return visit to the centre for this purpose).
Sponsors
Royal Adelaide Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed