Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus

• Conditions: Systemic Lupus
• Interventions: Biological: SRAS-CoV-2 vaccination immunological response

• Registration Number: NCT04894253
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-20
• Study Start: 2021-06-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group of 30 patients with systemic lupus	SRAS-CoV-2 vaccination immunological response	-

Primary Outcome Measures

Name	Time	Method
Investigation of the immune response following vaccination against SARS-CoV-2	18 months	Collection of clinical data and correlation with immunological analyzes of the biological samples

Secondary Outcome Measures

Name	Time	Method
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	18 months	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.

Trial Locations

Locations (1)

University Hospital of Hautepierre; 🇫🇷 Strasbourg, Bas-Rhin, France