COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases (COVIAAD)

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Rheumatic Diseases; Rheumatoid Arthritis; SLE
• Intervention / Treatment: Biological: Moderna COVID-19 vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Mcgill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria (all of the following):

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 (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vaccine; Study participants (People with rheumatic diseases and age matched controls).	Biological: Moderna 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
Geometric mean fold rise (GMFR) in IgG titer		baseline and Day 57

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): June 13, 2021
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; COVID-19; Rheumatic Diseases; Collagen Diseases; Autoimmune Diseases
• Other Study ID Numbers: MP-37-2021-7562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No