Clinical trial NCT04894253: Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus
Official title: Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic lupus, monitored and vaccinated at the national reference center for "rare systemic autoimmune diseases" of the University Hospitals of Strasbourg.

Brief summary: The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population.

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.


Eligibility criteria: Inclusion Criteria:

* Adult subject (≥ 18 years old), male or female
* 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:

* Patient treated by:

  * 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

Primary outcomes:
measure: Investigation of the immune response following vaccination against SARS-CoV-2
timeFrame: 3 or 4 weeks
measure: Investigation of the immune response following vaccination against SARS-CoV-2
timeFrame: 3 months
measure: Investigation of the immune response following vaccination against SARS-CoV-2
timeFrame: 6 months
measure: Investigation of the immune response following vaccination against SARS-CoV-2
timeFrame: 12 months
measure: Investigation of the immune response following vaccination against SARS-CoV-2
timeFrame: 18 months
Secondary outcomes:
measure: Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
timeFrame: 3 or 4 weeks
measure: Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
timeFrame: 3 months
measure: Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
timeFrame: 6 months
measure: Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
timeFrame: 12 months
measure: Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
timeFrame: 18 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Hautepierre
state: Bas-Rhin
Study officials:
References: