Acceptance and effectiveness of sars-cov-2 vaccination in systemic sclerosis patients treated by autologous hematopoietic stem cell transplantation – COV2-VACCinSSC

Acceptance and effectiveness of sars-cov-2 vaccination in systemic sclerosis patients treated by autologous hematopoietic stem cell transplantation – COV2-VACCinSSC

Health Data Hub declaration number: N° F20230726143350 (registered on 26/07/2023)

Data controller : : Assistance publique-Hôpitaux de Paris

Coordinating Investigator : Pr Dominique Farge (Paris Saint-Louis)
Principal investigator CHU Toulouse : Pr Grégory Pugnet (CHU Toulouse)

Relevant patients in France: Systemic Sclerosis patients who were offered SARS-CoV-2 vaccination program between January 1, 2021 and June 30, 2022, and :
– For the “case” group: having been autografted with hematopoietic stem cells between 01/01/1998 and 31/12/2020.
– For the “control” group: never having been autografted with hematopoietic stem cells before 06/30/2022.

Research objective : This research involves the analysis of health data already collected as part of the routine care of systemic sclerosis (SSc) patients. The aim is to evaluate the acceptance and efficacy of the SARS-COV-2 (COVID-19 virus) vaccination program offered between January 1, 2021 and June 30, 2022 to patients treated with hematopoietic stem cell auto-transplantation and to non-transplanted other frail patients. This is a retrospective case-control cohort study, with retrospective analysis of previously collected data.

To answer the research question, it is planned to analyze data collected from 72 patients followed and treated for Systemic Sclerosis, 36 of whom were treated with hematopoietic stem cell autotransplantation (cases) and 36 who did not receive this treatment (controls).

Information for patients included in the study in France: Patients included in the study will receive by post mail a specific information note for this study containing all the information relating to the study and their rights