NCT04894253

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

Same day

First QC Date

May 18, 2021

Last Update Submit

December 16, 2025

Conditions

Systemic Lupus

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response

    3 or 4 weeks

  • Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response

    3 months

  • Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response

    6 months

  • Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response

    12 months

  • Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response

    18 months

Study Arms (1)

Single group of 30 patients with systemic lupus

Biological: SRAS-CoV-2 vaccination immunological response

Interventions

SRAS-CoV-2 vaccination immunological responseBIOLOGICAL

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.

Single group of 30 patients with systemic lupus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Hautepierre

Strasbourg, Bas-Rhin, 67000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood with subsequent extraction of: * Serum * Peripheral blood mononuclear cell * RNA

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 20, 2021

Study Start

June 7, 2021

Primary Completion

June 7, 2021

Study Completion

December 22, 2023

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)