Back to resultsCOVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases (COVIAAD)
Primary Purpose
Covid19, Rheumatic Diseases, Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Moderna COVID-19 vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
Inclusion Criteria (all of the following):
- Adults ages 18 years and older;
For the cases, established diagnosis of:
- RA done by a rheumatologist according to the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria, OR
- 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;
- 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):
- Positive pregnancy test either at screening or just prior to each vaccine administration.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- 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.
- Diagnosis of hepatitis B, hepatitis C virus, or human immunodeficiency virus (HIV).
- History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- 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.
- Vaccines within the 2 weeks prior to any dose of COVID-19 vaccine or until 30 days after any dose of COVID-19 vaccine.
- Lactating female.
- Immunoglobulin therapy or blood products within the past month.
- Prior diagnosis of COVID-19 in the past 3 months.
- Planned changes in baseline drug treatments (except prednisone) for rheumatic diseases prior to D57.
- For patients required to be on cohort 8: Planned reduction of prednisone dose below 10 mg prior to D21.
Sites / Locations
- McGill University Health Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vaccine
Arm Description
Study participants (People with rheumatic diseases and age matched controls).
Outcomes
Primary Outcome Measures
Frequency and grade of each solicited local and systemic adverse events (AEs)
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.
Secondary Outcome Measures
Geometric mean titer (GMT) of antibody
Percentage of patients who seroconverted
defined as a 4-fold increase in antibody titer
Geometric mean fold rise (GMFR) in IgG titer
Full Information
NCT ID
NCT04806113
First Posted
March 12, 2021
Last Updated
March 17, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT04806113
Brief Title
COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
Acronym
COVIAAD
Official Title
COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
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
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Rheumatic Diseases, Rheumatoid Arthritis, SLE
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized, open label, comparative clinical trial with pragmatic features.
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Other
Arm Description
Study participants (People with rheumatic diseases and age matched controls).
Intervention Type
Biological
Intervention Name(s)
Moderna COVID-19 vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency and grade of each solicited local and systemic adverse events (AEs)
Time Frame
during a 7-day follow-up period post each vaccination
Title
Frequency and grade of any unsolicited AEs (including 'significant disease flares'*)
Description
* '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 Outcome Measure Information:
Title
Geometric mean titer (GMT) of antibody
Time Frame
at Day 57
Title
Percentage of patients who seroconverted
Description
defined as a 4-fold increase in antibody titer
Time Frame
baseline and Day 57
Title
Geometric mean fold rise (GMFR) in IgG titer
Time Frame
baseline and Day 57
Other Pre-specified Outcome Measures:
Title
Geometric mean titer (GMT) of antibody
Description
post-first vaccine dose
Time Frame
Day 28
Title
Geometric mean titer (GMT) of neutralizing antibody
Time Frame
Day 57
Title
CD4 and CD8 T cell responses
Description
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
Title
Effect of age on Geometric mean titer (GMT) in RA patients
Description
Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models.
Time Frame
baseline, Day 57
Title
Geometric mean titer (GMT) in RA versus age-matched controls
Description
Will be assessed by comparing RA versus HC in age adjusted models.
Time Frame
baseline, Day 57
Title
Geometric mean titer (GMT)
Time Frame
baseline, Month 6 and Month 12
Title
Percentage of patients who seroconverted
Description
defined as a 4-fold increase in neutralizing antibody titer
Time Frame
baseline, Day 57
Title
Geometric mean fold rise (GMFR) of neutralizing antibody titer
Time Frame
baseline, Day 57
Title
Effect of treatment on Geometric mean titer (GMT) in RA patients
Description
Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models.
Time Frame
baseline, Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (all of the following):
Adults ages 18 years and older;
For the cases, established diagnosis of:
RA done by a rheumatologist according to the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria, OR
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;
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):
Positive pregnancy test either at screening or just prior to each vaccine administration.
Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
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.
Diagnosis of hepatitis B, hepatitis C virus, or human immunodeficiency virus (HIV).
History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
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.
Vaccines within the 2 weeks prior to any dose of COVID-19 vaccine or until 30 days after any dose of COVID-19 vaccine.
Lactating female.
Immunoglobulin therapy or blood products within the past month.
Prior diagnosis of COVID-19 in the past 3 months.
Planned changes in baseline drug treatments (except prednisone) for rheumatic diseases prior to D57.
For patients required to be on cohort 8: Planned reduction of prednisone dose below 10 mg prior to D21.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Colmegna, DR
Organizational Affiliation
RI-MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
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