Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001249640
Ethics application status
Approved
Date submitted
3/11/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immune response to a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy
Scientific title
Immunogenicity of a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy
Secondary ID [1] 310892 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 331945 0
Immunosuppression 331946 0
COVID-19 vaccination 331948 0
Condition category
Condition code
Neurological 328676 328676 0 0
Multiple sclerosis
Infection 328677 328677 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 327316 0
Diagnosis / Prognosis
Comparator / control treatment
Trial is non-interventional - participants will be recruited who are receiving ongoing treatment for multiple sclerosis of natalizumab monoclonal antibody by intravenous infusion (300 mg, 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).
Control group
Active

Outcomes
Primary outcome [1] 336481 0
Any change in the proportion of participants who achieve effective neutralisation of live SARS-CoV-2 A.2.2, where effective neutralisation is defined as equal to or greater than 20.2% of mean IC50 of first-wave convalescent patients
Timepoint [1] 336481 0
Four weeks post third COVID-19 vaccine dose
Primary outcome [2] 336618 0
Any change in the proportion of participants who achieve effective neutralisation of live SARS-CoV-2 omicron BA.5, where effective neutralisation is defined as equal to or greater than 20.2% of mean IC50 of first-wave convalescent patients
Timepoint [2] 336618 0
Four weeks post third COVID-19 vaccine dose
Secondary outcome [1] 428537 0
T cell response
Timepoint [1] 428537 0
Change in response (immediately) pre to (4 weeks) post third COVID-19 mRNA vaccine dose
Secondary outcome [2] 428538 0
Post-vaccination anti-SARS-CoV-2 (Ancestral) Spike IgG
Timepoint [2] 428538 0
4 weeks post 3rd COVID-19 mRNA vaccine dose
Secondary outcome [3] 428539 0
Exploratory - Association of Peripheral Blood Immune Phenotype with antibody response to vaccination
Timepoint [3] 428539 0
Immediately prior to third COVID-19 mRNA vaccine dose
Secondary outcome [4] 429010 0
Post-vaccination anti-SARS-CoV-2 (Ancestral) Spike receptor-binding domain IgG
Timepoint [4] 429010 0
Four weeks post 3rd COVID-19 mRNA vaccine dose
Secondary outcome [5] 429011 0
Post-vaccination anti-SARS-CoV-2 (Ancestral) Spike IgM
Timepoint [5] 429011 0
4 weeks post 3rd COVID-19 mRNA vaccine dose
Secondary outcome [6] 429012 0
Post-vaccination anti-SARS-CoV-2 (Ancestral) Spike IgA
Timepoint [6] 429012 0
4 weeks post 3rd COVID-19 mRNA vaccine dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/11/2021
Date of last participant enrolment
Anticipated
Actual
31/08/2022
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
55
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315150 0
Charities/Societies/Foundations
Name [1] 315150 0
Health Services Charitable Gifts Board
Country [1] 315150 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
1 Port Road, Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 317168 0
None
Name [1] 317168 0
Address [1] 317168 0
Country [1] 317168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314086 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 314086 0
Ethics committee country [1] 314086 0
Australia
Date submitted for ethics approval [1] 314086 0
11/08/2021
Approval date [1] 314086 0
20/08/2021
Ethics approval number [1] 314086 0
15083

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130362 0
A/Prof Pravin Hissaria
Address 130362 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 130362 0
Australia
Phone 130362 0
+6108 8222 3489
Fax 130362 0
Email 130362 0
[email protected]
Contact person for public queries
Name 130363 0
Pravin Hissaria
Address 130363 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 130363 0
Australia
Phone 130363 0
+6108 8222 3489
Fax 130363 0
Email 130363 0
[email protected]
Contact person for scientific queries
Name 130364 0
Griffith Perkins
Address 130364 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 130364 0
Australia
Phone 130364 0
+610883130138
Fax 130364 0
Email 130364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.