Recruiting
Phase 2
Phase 3

COVID-19 Vaccine

Sponsor:

Paul R Fortin

Code:

NCT05236491

Conditions

Rheumatoid Arthritis

Autoimmune Rheumatologic Disease

Systemic Lupus Erythematosus

Systemic Vasculitis

Systemic Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COVID-19 vaccine

Study Details

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).

Conditions

Rheumatoid Arthritis

Autoimmune Rheumatologic Disease

Systemic Lupus Erythematosus

Systemic Vasculitis

Systemic Sclerosis

Study ID

NCT05236491

Start date

Mar 9, 2022

Status verified date

Jan, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. 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);
2. Has received 3 or more doses of an mRNA vaccine;
3. Age 18 years and older;
4. Male or non-pregnant female;
5. Rituximab treatment within last 12 months;
6. Able to comprehend the study protocol and provide informed consent.

Exclusion Criteria

1. Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation;
2. Significant behavioral disturbances;
3. Previous diagnosis of hepatitis B, hepatitis C or HIV;
4. History of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine;
5. 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.

Study Design

Enrollment

287 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Trajectory A

Participants 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.

no intervention: Trajectory B

Participants 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.

active comparator: Trajectory B5

Participants 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

COVID-19 vaccine

Participants are to receive a booster dose of a COVID-19 vaccine.

Primary outcome measure

  • Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb. [ Time Frame: 28 days ]
  • Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Paul R Fortin, MD,MPH,FRCPC

4185254444paul.fortin@crchudequebec.ulaval.ca

Alexandra Godbout, BA

4185254444alexandra.godbout@crchudequebec.ulaval.ca

Locations

Research Institute - McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Sonia Leger-Theriault

Sonia.Leger@MUHC.MCGILL.CA

Principal Investigator:

Inés Colmegna, MD

Centre de recherche du CHU de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Alexandra Godbout

alexandra.godbout@crchudequebec.ulaval.ca

More Information

Sponsor

Paul R Fortin

Last update posted

Jan 17, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul R Fortin on 2023-01-17.