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

Systemic Lupus Clinical Trial

— LUPCELLVAX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894253
• Other study ID #: 8263
• Status: Recruiting
• Start date: June 7, 2021
• Est. completion date: February 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Strasbourg, France
• Contact: Jean SIBILIA, MD
• Phone: 3 88 12 79 55
• Email: jean.sibilia[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Systemic Lupus

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Hautepierre	Strasbourg	Bas-Rhin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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