Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus (LUPCELLVAX)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Systemic Lupus

Treatments: Biological: SRAS-CoV-2 vaccination immunological response

Study type: Observational

Funder types: Other

Identifiers

NCT04894253

8263

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Single group of 30 patients with systemic lupus

Treatment:

Biological: SRAS-CoV-2 vaccination immunological response