Systemic Lupus ErythematosusEarly Phase 1NCT04839315
COVID-19 Vaccination in Rheumatic Disease Patients
A Early Phase 1 study testing mRNA COVD19 vaccine in people with Systemic Lupus Erythematosus and Sjogren's Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis
- What is being tested?
- mRNA COVD19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 9 Feb 2022
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatologist confirmed diagnosis of one of the following diagnoses:
- Systemic lupus erythematosus;
- Sjogren syndrome;
- Inflammatory myositis;
- Psoriatic arthritis;
- Osteoarthritis;
Show all 9Show fewer
- Gout;
- Ankylosing spondylitis;
- IBD-related arthritis.
Who cannot join
- Active infection or untreated malignancy (other than skin cancer) at enrollment.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.
Read the detailed description
Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.
- Conditions
- Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis, Psoriatic Arthritis, Gout, Ankylosing Spondylitis
- Being tested
- mRNA COVD19 vaccine
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Arthritis, Psoriatic, Gout, Spondylitis, Ankylosing, Disease, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA COVD19 vaccineBiological
Subjects will receive two doses of mRNA based COVID19 vaccines.
| Study group | Role | What they receive |
|---|---|---|
| mRNA COVID19 vaccines | Other | mRNA-based COVID19 vaccines Receives: Biological: mRNA COVD19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral responses towards mRNA COVID-19 vaccines
We aim to examine SARS-Cov2 specific antibody, and autoantibody generation
Measured: 2 weeks to 6 months after second dose of vaccine
Secondary outcomes (1)
Cellular immune responses towards mRNA COVID-19 vaccines
measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses
Measured: 2 weeks to 6 months after second dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Feb 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Why it stopped: Difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Zeng, Mayo Clinic
- Investigators
- Hu Zeng, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839315
- Sponsor's protocol ID
- 21-000501
- Status last verified
- May 2022
- First submitted
- 5 Apr 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04839315
- Acronym / sponsor ID
- 21-000501
- Conditions
- Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis, Psoriatic Arthritis, Gout, Ankylosing Spondylitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with enrollment
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 9 Apr 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.
The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.
Detailed description
Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA COVID19 vaccines | Other | Biological: mRNA COVD19 vaccinemRNA-based COVID19 vaccines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Rheumatologist confirmed diagnosis of one of the following diagnoses:
- Systemic lupus erythematosus;
- Sjogren syndrome;
- Inflammatory myositis;
- Psoriatic arthritis;
Key exclusion criteria (2 listed)
- Active infection or untreated malignancy (other than skin cancer) at enrollment.
- Pregnancy
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 |
|---|---|---|
| mRNA COVD19 vaccineSubjects will receive two doses of mRNA based COVID19 vaccines. | Biological | mRNA COVID19 vaccines |
Primary outcome
Humoral responses towards mRNA COVID-19 vaccines
Time frame: 2 weeks to 6 months after second dose of vaccine
We aim to examine SARS-Cov2 specific antibody, and autoantibody generation
1 secondary outcome
Cellular immune responses towards mRNA COVID-19 vaccines
Time frame: 2 weeks to 6 months after second dose of vaccine
Results and safety
The study was stopped early (reason given: Difficulty with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Hu Zeng, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mRNA COVD19 vaccine in people with Systemic Lupus Erythematosus and Sjogren's Syndrome, run by Mayo Clinic at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 3 Jun 2022. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Difficulty with enrollment). Results are not available in the source record.
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?
Humoral responses towards mRNA COVID-19 vaccines (time frame: 2 weeks to 6 months after second dose of vaccine). 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 3 Jun 2022.