NCT04870411

Brief Summary

Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics. In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate. Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators. Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known. The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2022

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

March 26, 2021

Last Update Submit

September 5, 2025

Conditions

Autoimmune DiseasesInflammatory Disorder

Keywords

Covid-19vaccineSARS-CoV2autoimmune diseasesimmunosuppressants

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with neutralizing antibody

    1 month after vaccination

Secondary Outcomes (23)

  • Proportion of patients with neutralizing antibody

    3 months after vaccination

  • Proportion of patients with neutralizing antibody

    6 months after vaccination

  • Proportion of patients with neutralizing antibody

    12 months after vaccination

  • Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    1 month after vaccination

  • Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    3 months after vaccination

  • +18 more secondary outcomes

Study Arms (2)

Patients with auto-immune or autoinflammatory diseases

Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics

Biological: Blood sample

Patients without auto-immune or autoinflammatory diseases

Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination

Patients with auto-immune or autoinflammatory diseasesPatients without auto-immune or autoinflammatory diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics = 170 patients Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics = 30 patients

You may qualify if:

  • Group 1 :
  • Patient over 18 years old,
  • Patient informed and not opposed to participate
  • Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
  • Treatment with immunosuppressant and / or immunomodulator
  • Group 2 :
  • Patient over 18 years old,
  • Patient informed and not opposed to participate
  • Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
  • Absence of treatment with immunosuppressant and / or immunomodulator

You may not qualify if:

  • Contraindication to vaccination
  • Progressive cancer
  • Pregnant or breastfeeding woman
  • Current infection less than 3 weeks old
  • Weight less than 40 kg
  • Patient under tutor- or curator-ship
  • Patient without health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal medicine Service - Cochin Hospital

Paris, 75014, France

Location

Related Publications (5)

  • Welzel D, Roskamm N, Samek L, Sturzenhofecker P. Pindolol postmyocardial infarction study: evaluation of the drug's antiarrhythmic and antianginal activity. Am Heart J. 1982 Aug;104(2 Pt 2):512-5. doi: 10.1016/0002-8703(82)90148-x.

    PMID: 7102538BACKGROUND

  • Cameron MM, Milligan PJ, Llanos-Cuentas A, Davies CR. An association between phlebotomine sandflies and aphids in the Peruvian Andes. Med Vet Entomol. 1995 Apr;9(2):127-32. doi: 10.1111/j.1365-2915.1995.tb00168.x.

    PMID: 7787219BACKGROUND

  • Scholes J, Freeman M. The reflective dialogue and repertory grid: a research approach to identify the unique contribution of nursing, midwifery or health visiting to the therapeutic milieu. J Adv Nurs. 1994 Nov;20(5):885-93. doi: 10.1046/j.1365-2648.1994.20050885.x.

    PMID: 7745181BACKGROUND

  • Sacre K, Goulenok T, Bahuaud M, Francois C, Van der Haegen MC, Alexandra JF, Aucouturier P, Hurtado-Nedelec M, Moins-Teisserenc H, Batteux F, Papo T. Impaired long-term immune protection following pneumococcal 13-valent/23-valent polysaccharide vaccine in systemic lupus erythematosus (SLE). Ann Rheum Dis. 2018 Oct;77(10):1540-1542. doi: 10.1136/annrheumdis-2017-212789. Epub 2018 Feb 14. No abstract available.

    PMID: 29444908BACKGROUND

  • Hadjadj J, Planas D, Ouedrani A, Buffier S, Delage L, Nguyen Y, Bruel T, Stolzenberg MC, Staropoli I, Ermak N, Macraigne L, Morbieu C, Henriquez S, Veyer D, Pere H, Casadevall M, Mouthon L, Rieux-Laucat F, Chatenoud L, Schwartz O, Terrier B. Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases. Ann Rheum Dis. 2022 May;81(5):720-728. doi: 10.1136/annrheumdis-2021-221508. Epub 2022 Jan 12.

    PMID: 35022159BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and cells

MeSH Terms

Conditions

Autoimmune DiseasesCOVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

May 3, 2021

Study Start

May 12, 2021

Primary Completion

August 31, 2021

Study Completion

March 13, 2022

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)