Systemic SclerosisCOV2-VACCinSScNCT05960058
Acceptance and Effectiveness of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Vaccination in Systemic Sclerosis Patients Treated by Autologous Hematopoietic Stem Cell Transplantation
An observational study of Systemic Sclerosis and SARS-CoV 2 Vaccination, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Sclerosis, SARS-CoV 2 Vaccination
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Systemic Sclerosis
Who may be able to join
- Adults SSc patients fulfilling criteria from the American College of Rheumatology- European League Against Rheumatism for systemic sclerosis, the 1980 criteria from the American College of Rheumatology for systemic sclerosis
- SSc patients who were offered SARS-CoV-2 vaccination program according to French GCP (with at least either a two-dose mRNA vaccine or single-dose adenoviral vector) between Jan 1st 2021 to June 30th 2022
- a) Cases: SSc patients, actively followed on Jan 1st 2021 and who underwent treatment by AHSCT therapy from 1998 up to December 31st 2020 b) Controls (non AHSCT): SSc patients, actively followed on Jan 1st 2021 and who had not undergone treatment by AHSCT at that time nor up to June 30th 2022
- Informed patients followed at Filière des maladies Auto-immunes et Auto Inflammatoires Rares (FAI2R) systemic sclerosis centers: either Centre de Référence des Maladies Rares (CRMR) MATHEC, Maladies Auto-immunes et Thérapie Cellulaire" at Saint-Louis hospital (Paris) or from "Service de Médecine Interne et Immunologie Clinique" at Rangueil hospital (Toulouse).
Who cannot join
- 1. SSc patient who were opposed to their data analysis after information about the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acceptance and Effectiveness of SARS-COV-2 Vaccination in Systemic Sclerosis Patients Treated by Autologous Hematopoietic Stem Cell Transplantation
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.
Read more
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.
- Conditions
- Systemic Sclerosis, SARS-CoV 2 Vaccination
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases (Autologous Haematopoietic Stem Cell Transplantation (AHSCT)) | Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021 | |
| Controls (without Autologous Haematopoietic Stem Cell Transplantation) | Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Secondary outcomes (6)
Proportion of SSc patients, previously treated by AHSCT and in non-transplant controls, who refused vaccination during the study period
Measured: Up to 18 months
Cumulative incidence of symptomatic COVID-19 infection in SSc patients previously treated by AHSCT and in non-transplant controls
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960058
- Sponsor's protocol ID
- APHP230473
- Acronym
- COV2-VACCinSSc
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Effectiveness of SARS-COV-2 Vaccination in Systemic Sclerosis Patients Treated by Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05960058
- Acronym / sponsor ID
- COV2-VACCinSSc / APHP230473
- Conditions
- Systemic Sclerosis, SARS-CoV 2 Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases (Autologous Haematopoietic Stem Cell Transplantation (AHSCT)) | – | –Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021 |
| Controls (without Autologous Haematopoietic Stem Cell Transplantation) | – | –Systemic Sclerosis (SSc) patients treated by AHSCT and actively followed at Saint Louis on January 1st, 2021 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Systemic Sclerosis
Key inclusion criteria (4 listed)
- Adults SSc patients fulfilling criteria from the American College of Rheumatology- European League Against Rheumatism for systemic sclerosis, the 1980 criteria from the American College of Rheumatology for systemic sclerosis
- SSc patients who were offered SARS-CoV-2 vaccination program according to French GCP (with at least either a two-dose mRNA vaccine or single-dose adenoviral vector) between Jan 1st 2021 to June 30th 2022
- a) Cases: SSc patients, actively followed on Jan 1st 2021 and who underwent treatment by AHSCT therapy from 1998 up to December 31st 2020 b) Controls (non AHSCT): SSc patients, actively followed on Jan 1st 2021 and who had not undergone treatment by AHSCT at that time nor up to June 30th 2022
- Informed patients followed at Filière des maladies Auto-immunes et Auto Inflammatoires Rares (FAI2R) systemic sclerosis centers: either Centre de Référence des Maladies Rares (CRMR) MATHEC, Maladies Auto-immunes et Thérapie Cellulaire" at Saint-Louis hospital (Paris) or from "Service de Médecine Interne et Immunologie Clinique" at Rangueil hospital (Toulouse).
Key exclusion criteria (1 listed)
- 1. SSc patient who were opposed to their data analysis after information about the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of asymptomatic or symptomatic COVID-19 infection after AHSCT as compared to non AHSCT SSc patients.
Time frame: Up to 18 months
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.
6 secondary outcomes
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
Time frame: Up to 18 months
Proportion of SSc patients with at least 1 grade≥3 adverse event after COVID19 vaccination
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
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and SARS-CoV 2 Vaccination, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Farge, Pr (+33142499768, dominique.farge-bancel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of asymptomatic or symptomatic COVID-19 infection after AHSCT as compared to non AHSCT SSc patients. (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.