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

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ClinicalTrials.gov Identifier: NCT04806113
Recruitment Status : Active, not recruiting
First Posted : March 19, 2021
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
CHU de Quebec-Universite Laval
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Covid19 Rheumatic Diseases Rheumatoid Arthritis SLE Biological: Moderna COVID-19 vaccine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized, open label, comparative clinical trial with pragmatic features.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : March 11, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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'*) [ Time Frame: during the 28-day follow-up period post-each vaccine dose. ]
    * 'Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy.


Secondary Outcome Measures :
  1. Geometric mean titer (GMT) of antibody [ Time Frame: at Day 57 ]
  2. Percentage of patients who seroconverted [ Time Frame: baseline and Day 57 ]
    defined as a 4-fold increase in antibody titer

  3. Geometric mean fold rise (GMFR) in IgG titer [ Time Frame: baseline and Day 57 ]

Other Outcome Measures:
  1. Geometric mean titer (GMT) of antibody [ Time Frame: Day 28 ]
    post-first vaccine dose

  2. Geometric mean titer (GMT) of neutralizing antibody [ Time Frame: Day 57 ]
  3. CD4 and CD8 T cell responses [ Time Frame: baseline, Day 57 ]
    percent of CD4 and CD8 T cells that produce IFNγ following exposure to overlapping peptide pool representing the vaccine-encoded receptor binding domain (RBD).

  4. Effect of age on Geometric mean titer (GMT) in RA patients [ Time Frame: baseline, Day 57 ]
    Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models.

  5. Geometric mean titer (GMT) in RA versus age-matched controls [ Time Frame: baseline, Day 57 ]
    Will be assessed by comparing RA versus HC in age adjusted models.

  6. Geometric mean titer (GMT) [ Time Frame: baseline, Month 6 and Month 12 ]
  7. Percentage of patients who seroconverted [ Time Frame: baseline, Day 57 ]
    defined as a 4-fold increase in neutralizing antibody titer

  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 [ Time Frame: baseline, Day 57 ]
    Will be assessed by comparing RA treated with JAKs versus biologics versus RTX in age adjusted models.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806113


Locations
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Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
CHU de Quebec-Universite Laval
Ministere de la Sante et des Services Sociaux
Investigators
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Principal Investigator: Ines Colmegna, DR RI-MUHC
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Responsible Party: Ines Colmegna, MD, Associate Professor, Rheumatology - Department of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04806113    
Other Study ID Numbers: MP-37-2021-7562
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Autoimmune Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Immune System Diseases