COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases
COVBIRD
1 other identifier
interventional
287
1 country
2
Brief Summary
People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)), a medication used to treat inflammatory types of arthritis, have extremely low immunity post-COVID-19 mRNA vaccine. This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Mar 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 17, 2023
January 1, 2023
1.2 years
February 10, 2022
January 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Assessment of SARDs flares (self-reported and physician-confirmed) in relation to the time of the last dose of vaccine received. The frequency of 'significant flares' will be defined as worsening of RA symptoms (i.e., increase in DAS28 \>1.2 or \>0.6 if DAS28 at baseline was ≥3.2) with an increase in the number of swollen joints confirmed by a rheumatologist that is actionable (requires treatment intensification). For SLE, a flare will be defined as mild/moderate when the index SLEDAI increases by \>3 and severe when it increases by \>10. The need for treatment intensification (e.g., increase in the dose of steroids) will also be recorded as an indication of SLE flare. For AAV and other SARDs that do not have standard instruments to define flares, we will use the physician's assessment of the presence of a clinically significant flare to the general question " Has this patient experienced a clinically significant flare of their SARD? " and document relevant change in medication.
28 days
Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Documentation of the reactogenicity to the booster dose of the vaccine. Reactogenicity post-booster dose will be based on the patient's diary and questionnaire collected at visit 28 days post booster dose vaccination.
28 days
Secondary Outcomes (1)
Humoral response
28 days post vaccination
Other Outcomes (2)
Humoral response
180 days post vaccination
Humoral response
335 days post vaccination
Study Arms (3)
Trajectory A
ACTIVE COMPARATORParticipants who have received 3 doses of an mRNA vaccine, will be offered a choice between a fourth dose of an mRNA vaccine and a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg). For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.
Trajectory B
NO INTERVENTIONParticipants who have already received a 4 doses or more of COVID-19 vaccine in the community at inclusion and do not wish to receive a 5th dose of vaccine in the study.
Trajectory B5
ACTIVE COMPARATORParticipants who have received 4 doses of an mRNA vaccine at inclusion and wish to receive a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) as a fifth dose. For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.
Interventions
Participants are to receive a booster dose of a COVID-19 vaccine.
Eligibility Criteria
You may qualify if:
- Diagnosis of a SARD (Rheumatoid arthritis, systemic lupus erythematosus (SLE), juvenile inflammatory arthritis, systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), overlap connective tissue diseases, mixed connective tissue disease, undifferentiated connective tissue diseases, giant-cell arteritis, and the ANCA-Associated Vasculitis: granulomatosis with polyangiitis (GPA; formerly known as Wegener's granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome);
- Has received 3 or more doses of an mRNA vaccine;
- Age 18 years and older;
- Male or non-pregnant female;
- Rituximab treatment within last 12 months;
- Able to comprehend the study protocol and provide informed consent.
You may not qualify if:
- Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation;
- Significant behavioral disturbances;
- Previous diagnosis of hepatitis B, hepatitis C or HIV;
- History of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine;
- People who experienced inflammation of the heart or lining of the heart (myocarditis or pericarditis) after a previous dose of an mRNA vaccine or protein subunit vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul R Fortinlead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (2)
Research Institute - McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, G1V 4G2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R Fortin, MD,MPH,FRCPC
Centre de recherche du CHU de Québec - Université Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Rheumatologist, Clinical Researcher, Principal Investigator
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 11, 2022
Study Start
March 9, 2022
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share