COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

Rheumatoid Arthritis Clinical Trial

— COVIAAD  

Official title:

COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806113
• Other study ID #: MP-37-2021-7562
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 15, 2022
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Collagen Diseases
• COVID-19
• Covid19
• Rheumatic Diseases
• Rheumatoid Arthritis
• SLE

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric mean titer (GMT) of antibody	post-first vaccine dose	Day 28
Other	Geometric mean titer (GMT) of neutralizing antibody		Day 57
Other	CD4 and CD8 T cell responses	percent of CD4 and CD8 T cells that produce IFN? following exposure to overlapping peptide pool representing the vaccine-encoded receptor binding domain (RBD).	baseline, Day 57
Other	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
Other	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
Other	Geometric mean titer (GMT)		baseline, Month 6 and Month 12
Other	Percentage of patients who seroconverted	defined as a 4-fold increase in neutralizing antibody titer	baseline, Day 57
Other	Geometric mean fold rise (GMFR) of neutralizing antibody titer		baseline, Day 57
Other	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
Primary	Frequency and grade of each solicited local and systemic adverse events (AEs)		during a 7-day follow-up period post each vaccination
Primary	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	Geometric mean titer (GMT) of antibody		at Day 57
Secondary	Percentage of patients who seroconverted	defined as a 4-fold increase in antibody titer	baseline and Day 57
Secondary	Geometric mean fold rise (GMFR) in IgG titer		baseline and Day 57