An observational study in Systemic Sclerosis and SARS-CoV 2 Vaccination, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
On December 27th 2020, the implementation of SARS-CoV-2 vaccination in France first became available amongst all immunosuppressed patients at very high risk of severe Coronavirus Disease (COVID-19) infection, specifically for Hematopoietic Stem Cell Transplant recipients or other fragile immunosuppressed patients.
Systemic sclerosis (SSc) is an autoimmune disease characterized by dysregulation of the immune system, vascular damage and progressive fibrosis of the skin and internal organs (heart, lung and kidney) which may lead to severe comorbidities and SSc-related mortality. In severe rapidly progressive SSc, we and others demonstrated that autologous hematopoietic stem cell transplantation (AHSCT) is the only treatment so far allowing improvement in overall and event free survival up to 7 years after AHSCT.
As soon as vaccines were available on January 1st, 2021 and following the French Haute Autorité de Santé (HAS) and Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) good clinical practices (GCP) guidelines, the ad hoc COVID19 vaccinations were proposed to all SSc patients in France, including those previously treated by AHSCT and followed at Maladies Auto Immunes et Thérapie Cellulaire (MATHEC) Center of Reference for stem cell therapy at St-Louis hospital. In July 2021, the Autoimmune Diseases Working Party (ADWP) and the European society for Blood and Marrow Transplantation (EBMT) guidelines recommended vaccination against SARS-CoV2 as early as 3 months after HSCT for autoimmune diseases.
Only one Israeli study so far has analyzed the efficacy of SARS-CoV-2 vaccination after autologous HSCT (AHSCT) in SSc patients..
We therefore designed the present case control study retrospective study to assess the acceptance and effectiveness of this vaccination program in SSc patients treated by AHSCT as compared to other fragile SSc individuals.
The Primary objective is to evaluate the effectiveness of implementing the anti-SARS-CoV2 vaccination program according to the French GCP for COVID-19 prophylaxis in SSc fragile patients, in terms of risk of asymptomatic or symptomatic COVID-19 infection, among SSc patients treated by AHSCT compared to 1:1 matched non transplant SSc controls.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Systemic Sclerosis
Exclusion Criteria:
Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021
Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021
Cumulative incidence of asymptomatic or symptomatic COVID-19 infection after AHSCT as compared to non AHSCT SSc patients.
Asymptomatic COVID-19 are defined by positive Polymerase Chain Polymerase (PCR) on routine testing (contact case or fortuitous discovery). Symptomatic COVID-19 patients are defined by positive PCR test and clinical symptoms related to COVID-19 infection.
Time frame: Up to 18 months
Proportion of SSc patients, previously treated by AHSCT and in non-transplant controls, who refused vaccination during the study period
Time frame: Up to 18 months
Cumulative incidence of symptomatic COVID-19 infection in SSc patients previously treated by AHSCT and in non-transplant controls
Time frame: Up to 18 months
Time of onset of first COVID-19 infection (symptomatic or asymptomatic) diagnosed during the study period after completing at least 2 vaccines injections in SSc patients previously treated by AHSCT and in non-transplant controls
Time frame: Up to 18 months
Severity of symptomatic COVID-19
It is assessed and classified according to the care needed for each patient: asymptomatic; mild=ambulatory; moderate=hospitalised out of Intensive Care Unit (ICU); and severe=ICU or deceased
Time frame: Up to 18 months
Proportion of SSc patients with at least 1 grade≥3 adverse event after COVID19 vaccination
It is assessed according to Common Terminology Criteria for Adverse Events (CTC-AE v5.0)
Time frame: Up to 18 months
Humoral response in SSc patients treated by AHSCT and in controls after messenger RiboNucleic Acid (mRNA) vaccine against SARS-CoV
It is assessed as positive or negative, according to the presence of SARS-CoV-2 S1/S2 Immunoglobulin G (IgG) antibodies on serological test performed after the second vaccine dose or after 1 vaccine and one COVID-19 infection. Patients were considered positive or negative for being able to mount a humoral response according to national GCP guidelines (last update March 2022).The threshold for a positive immunogenic response was defined by local laboratory standards according to the manufacturer's instructions for cut-off values.
Time frame: Up to 18 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris