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| Name | Class |
|---|---|
| CHU de Quebec-Universite Laval | OTHER |
| Ministere de la Sante et des Services Sociaux | OTHER |
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This study will evaluate the Moderna RNA-based COVID-19 vaccine currently approved by Health Canada in people with rheumatic diseases. This study will help understand what the side effects of the vaccine in these patients are, and what is their capacity to develop antibodies that may confer protection from the COVID-19 disease.
The purpose of this study is to evaluate the safety, local reactions (reactogenicity), capacity to form antibodies against the coronavirus (immunogenicity) and long-term persistence of those antibodies following two doses of a Health Canada approved RNA-based COVID-19 vaccine in patients with rheumatic diseases.
Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days.
This research study will recruit 220 participants (165 patients and 55 healthy controls), men and women, aged 18 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Other | Study participants (People with rheumatic diseases and age matched controls). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderna COVID-19 vaccine | Biological | Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and grade of each solicited local and systemic adverse events (AEs) | during a 7-day follow-up period post each vaccination | |
| Frequency and grade of any unsolicited AEs (including 'significant disease flares'*) | * 'Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy. | during the 28-day follow-up period post-each vaccine dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of antibody | at Day 57 | |
| Percentage of patients who seroconverted | defined as a 4-fold increase in antibody titer | baseline and Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of antibody | post-first vaccine dose | Day 28 |
| Geometric mean titer (GMT) of neutralizing antibody | Day 57 | |
Inclusion Criteria (all of the following):
Adults ages 18 years and older;
For the cases, established diagnosis of:
For the cases, stable treatment (≥3 months prior to enrollment for biologics/small molecules and MMF; >3 weeks of a specific dose in case of steroids);
For the controls, people without a diagnosis of a chronic rheumatic disease who can have comorbidities as in patients with rheumatic diseases;
Able to comprehend the investigational nature of the protocol and provide informed consent;
Male or non-pregnant female;
Women of childbearing potential must agree to use at least one acceptable primary form of contraception.
Exclusion Criteria (any of the following):
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| Name | Affiliation | Role |
|---|---|---|
| Ines Colmegna, DR | RI-MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012216 | Rheumatic Diseases |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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Non-randomized, open label, comparative clinical trial with pragmatic features.
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| Geometric mean fold rise (GMFR) in IgG titer | baseline and Day 57 |
| CD4 and CD8 T cell responses |
percent of CD4 and CD8 T cells that produce IFNγ following exposure to overlapping peptide pool representing the vaccine-encoded receptor binding domain (RBD). |
| baseline, Day 57 |
| Effect of age on Geometric mean titer (GMT) in RA patients | Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models. | baseline, Day 57 |
| Geometric mean titer (GMT) in RA versus age-matched controls | Will be assessed by comparing RA versus HC in age adjusted models. | baseline, Day 57 |
| Geometric mean titer (GMT) | baseline, Month 6 and Month 12 |
| Percentage of patients who seroconverted | defined as a 4-fold increase in neutralizing antibody titer | baseline, Day 57 |
| Geometric mean fold rise (GMFR) of neutralizing antibody titer | baseline, Day 57 |
| Effect of treatment on Geometric mean titer (GMT) in RA patients | Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models. | baseline, Day 57 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |