Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus
NCT ID: NCT04894253
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
7 participants
OBSERVATIONAL
2021-06-07
2023-12-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2.
The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single group of 30 patients with systemic lupus
SRAS-CoV-2 vaccination immunological response
Follow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination.
Intervention includes immunological analysis on additional volume of blood collected as part of routine care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SRAS-CoV-2 vaccination immunological response
Follow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination.
Intervention includes immunological analysis on additional volume of blood collected as part of routine care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with systemic lupus according to ACR 1997 criteria
* Patient followed by the National Reference Center "Rare Systemic Autoimmune Diseases" of the University Hospitals of Strasbourg
* Patient who agreed to be vaccinated against SARS-CoV-2
* Subject having expressed his non-opposition to the research
* Subject affiliated to a social health insurance protection scheme
Exclusion Criteria
* Corticosteroids (\> = 10mg / day)
* Immunosuppressant (azathioprine, mycophenolate mofetil, cyclophosphamide) to control lupus activity
* A biomedicine targeting B cells (rituximab, belumimab).
* Inability to provide informed information about the subject (subject in an emergency, difficulty in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Hautepierre
Strasbourg, Bas-Rhin, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
8263
Identifier Type: -
Identifier Source: org_study_id