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CompletedNCT04806113COVIAADUpdated Mar 20, 2023

COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

A Phase 3 interventional study of Moderna COVID-19 vaccine in Covid19, Rheumatic Diseases and Rheumatoid Arthritis, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Covid19
  • Rheumatic Diseases
  • Rheumatoid Arthritis
  • SLE
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 220 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adults ages 18 years and older;

  2. For the cases, established diagnosis of:

    1. RA done by a rheumatologist according to the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria, OR
    2. SLE done by a rheumatologist according to the 1997 revised ACR criteria and/or the 2013 SLICC lupus classification criteria and/or the 2019 EULAR/ACR criteria;
  3. 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);
  4. For the controls, people without a diagnosis of a chronic rheumatic disease who can have comorbidities as in patients with rheumatic diseases;
  5. Able to comprehend the investigational nature of the protocol and provide informed consent;
  6. Male or non-pregnant female;
  7. Women of childbearing potential must agree to use at least one acceptable primary form of contraception.

Exclusion criteria

Exclusion Criteria (any of the following):

  1. Positive pregnancy test either at screening or just prior to each vaccine administration.
  2. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
  3. Acute illness, as determined by the site PI or appropriate sub-investigator, with or without fever [oral temperature >38.0°C (100.40F)] within 72 hours prior to each vaccination.
  4. Diagnosis of hepatitis B, hepatitis C virus, or human immunodeficiency virus (HIV).
  5. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
  6. Participation in another clinical trial or plan to do so during the study. If a patient was on a drug trial, recruitment could occur following 2 half-lives of the study drug.
  7. Vaccines within the 2 weeks prior to any dose of COVID-19 vaccine or until 30 days after any dose of COVID-19 vaccine.
  8. Lactating female.
  9. Immunoglobulin therapy or blood products within the past month.
  10. Prior diagnosis of COVID-19 in the past 3 months.
  11. Planned changes in baseline drug treatments (except prednisone) for rheumatic diseases prior to D57.
  12. For patients required to be on cohort 8: Planned reduction of prednisone dose below 10 mg prior to D21.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Other
    Vaccine

    Study participants (People with rheumatic diseases and age matched controls).

    Biological: Moderna COVID-19 vaccine

Interventions

  • BiologicalModerna COVID-19 vaccine

    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.

06

What researchers measure

Primary outcomes

  1. Frequency and grade of each solicited local and systemic adverse events (AEs)

    Time frame: during a 7-day follow-up period post each vaccination

  2. 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.

    Time frame: during the 28-day follow-up period post-each vaccine dose.

Secondary outcomes

  1. Geometric mean titer (GMT) of antibody

    Time frame: at Day 57

  2. Percentage of patients who seroconverted

    defined as a 4-fold increase in antibody titer

    Time frame: baseline and Day 57

  3. Geometric mean fold rise (GMFR) in IgG titer

    Time frame: baseline and Day 57

Other outcomes

  1. Geometric mean titer (GMT) of antibody

    post-first vaccine dose

    Time frame: Day 28

  2. Geometric mean titer (GMT) of neutralizing antibody

    Time frame: Day 57

  3. 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).

    Time frame: baseline, Day 57

  4. 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.

    Time frame: baseline, Day 57

  5. Geometric mean titer (GMT) in RA versus age-matched controls

    Will be assessed by comparing RA versus HC in age adjusted models.

    Time frame: baseline, Day 57

  6. Geometric mean titer (GMT)

    Time frame: baseline, Month 6 and Month 12

  7. Percentage of patients who seroconverted

    defined as a 4-fold increase in neutralizing antibody titer

    Time frame: baseline, Day 57

  8. Geometric mean fold rise (GMFR) of neutralizing antibody titer

    Time frame: baseline, Day 57

  9. 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.

    Time frame: baseline, Day 57

07

Study locations

1 site
  • McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04806113
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
CHU de Quebec-Universite Laval, Ministere de la Sante et des Services Sociaux
Responsible party
Ines Colmegna (MD, Associate Professor, Rheumatology - Department of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Mar 19, 2021
Start date
Mar 11, 2021
Primary completion
Jun 13, 2021
Completion
Jun 15, 2022
Last update
Mar 20, 2023

Study contacts

Ines Colmegna, DR
principal investigator · RI-MUHC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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