Covid19Phase 3COVIAADNCT04806113
COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
A Phase 3 study testing Moderna COVID-19 vaccine in people with Covid19 and Rheumatic Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Rheumatic Diseases, Rheumatoid Arthritis
- What is being tested?
- Moderna COVID-19 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 11 Mar 2021to 15 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid19, Rheumatic Diseases, Rheumatoid Arthritis, SLE
- Being tested
- Moderna COVID-19 vaccine
- Medical subject headings
- COVID-19, Rheumatic Diseases, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderna COVID-19 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Other | Study participants (People with rheumatic diseases and age matched controls). Receives: Biological: Moderna COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and grade of each solicited local and systemic adverse events (AEs)
Measured: 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.
Measured: during the 28-day follow-up period post-each vaccine dose.
Secondary outcomes (3)
Geometric mean titer (GMT) of antibody
Measured: at Day 57
Percentage of patients who seroconverted
defined as a 4-fold increase in antibody titer
Measured: baseline and Day 57
Geometric mean fold rise (GMFR) in IgG titer
Measured: baseline and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start11 Mar 2021
- Primary completion13 Jun 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, open label, comparative clinical trial with pragmatic features.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Ministere de la Sante et des Services Sociaux
- Responsible party
- Principal investigator, Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ines Colmegna, DR, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806113
- Sponsor's protocol ID
- MP-37-2021-7562
- Acronym
- COVIAAD
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT04806113
- Acronym / sponsor ID
- COVIAAD / MP-37-2021-7562
- Conditions
- Covid19, Rheumatic Diseases, Rheumatoid Arthritis, SLE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Ministere de la Sante et des Services Sociaux
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, open label, comparative clinical trial with pragmatic features.
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Other | Biological: Moderna COVID-19 vaccineStudy participants (People with rheumatic diseases and age matched controls). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ages 18 years and older;
- For the cases, established diagnosis of:
- 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;
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderna COVID-19 vaccineTwo doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days. | Biological | Vaccine |
Primary outcome
Frequency and grade of each solicited local and systemic adverse events (AEs)
Time frame: during a 7-day follow-up period post each vaccination
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.
3 secondary outcomes
Geometric mean titer (GMT) of antibody
Time frame: at Day 57
Percentage of patients who seroconverted
Time frame: baseline and Day 57
Geometric mean fold rise (GMFR) in IgG titer
Time frame: baseline and Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Colmegna, DR principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moderna COVID-19 vaccine in people with Covid19 and Rheumatic Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and grade of each solicited local and systemic adverse events (AEs) (time frame: during a 7-day follow-up period post each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.