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

Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus

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.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus
• Intervention / Treatment: Biological: SRAS-CoV-2 vaccination immunological response

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • University Hospital of Hautepierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single group of 30 patients with systemic lupus	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of the immune response following vaccination against SARS-CoV-2	Collection of clinical data and correlation with immunological analyzes of the biological samples	3 or 4 weeks
Investigation of the immune response following vaccination against SARS-CoV-2	Collection of clinical data and correlation with immunological analyzes of the biological samples	3 months
Investigation of the immune response following vaccination against SARS-CoV-2	Collection of clinical data and correlation with immunological analyzes of the biological samples	6 months
Investigation of the immune response following vaccination against SARS-CoV-2	Collection of clinical data and correlation with immunological analyzes of the biological samples	12 months
Investigation of the immune response following vaccination against SARS-CoV-2	Collection of clinical data and correlation with immunological analyzes of the biological samples	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.	3 or 4 weeks
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.	3 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.	6 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.	12 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response	Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No