COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

NCT04806113 | Completed Phase 3

• 1 other identifier: MP-37-2021-7562
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Rheumatic Diseases; Rheumatoid Arthritis; SLE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Geometric mean titer (GMT) of antibody

  at Day 57

• Percentage of patients who seroconverted

  baseline and Day 57

• Geometric mean fold rise (GMFR) in IgG titer

  baseline and Day 57

Other Outcomes (9)

• Geometric mean titer (GMT) of antibody

  Day 28

• Geometric mean titer (GMT) of neutralizing antibody

  Day 57

• CD4 and CD8 T cell responses

  baseline, Day 57

Study Arms (1)

Vaccine

OTHER

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

Biological: Moderna COVID-19 vaccine

Interventions

Moderna COVID-19 vaccine BIOLOGICAL

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.

Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• CHU de Quebec-Universite Laval: collaborator
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

COVID-19; Rheumatic Diseases; Arthritis, Rheumatoid

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Ines Colmegna, DR

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor, Rheumatology - Department of Medicine

Model Details: Non-randomized, open label, comparative clinical trial with pragmatic features.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 19, 2021
• Study Start: March 11, 2021
• Primary Completion: June 13, 2021
• Study Completion: June 15, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)