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| Name | Class |
|---|---|
| Centre Hospitalier Régional et Universitaire de Brest | OTHER |
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COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serological COVID-19 vaccine immunogenicity | Biological | Serological test |
|
| Measure | Description | Time Frame |
|---|---|---|
| antibody synthesis induced after Covid-19 vaccination (positive or negative) | evaluation of IgG anti-S level | 1 month after 2nd injection |
| Measure | Description | Time Frame |
|---|---|---|
| Lack of immunogenicity | evaluation of IgG anti-S level | day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months |
| COVID-19 incidence | day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis B-vaccination response | Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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all in-center haemodialysis patients eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Quimper | Quimper | 29000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32979369 | Result | Jager KJ, Kramer A, Chesnaye NC, Couchoud C, Sanchez-Alvarez JE, Garneata L, Collart F, Hemmelder MH, Ambuhl P, Kerschbaum J, Legeai C, Del Pino Y Pino MD, Mircescu G, Mazzoleni L, Hoekstra T, Winzeler R, Mayer G, Stel VS, Wanner C, Zoccali C, Massy ZA. Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe. Kidney Int. 2020 Dec;98(6):1540-1548. doi: 10.1016/j.kint.2020.09.006. Epub 2020 Oct 15. | |
| 33340043 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Death during follow up | day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months |
| measure antibody response to vaccines in patient subgroup (diabetic patients, patients with auto-immune disease, patients with cancer, patients with an history of solid organ transplantation) | evaluation of IgG anti-S level | day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months |
| Longevity of the antibody synthesis induced after Covid-19 vaccination | evaluation of IgG anti-S level | 3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection |
| antibody synthesis induced after one injection of Covid-19 vaccine | evaluation of IgG anti-S level | before second injection |
| Result |
| ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314. |
| 17897251 | Result | Eleftheriadis T, Antoniadi G, Liakopoulos V, Kartsios C, Stefanidis I. Disturbances of acquired immunity in hemodialysis patients. Semin Dial. 2007 Sep-Oct;20(5):440-51. doi: 10.1111/j.1525-139X.2007.00283.x. |
| 33230249 | Result | Mahalingasivam V, Tomlinson L. The seroprevalence of SARS-CoV-2 in patients on haemodialysis. Nat Rev Nephrol. 2021 Apr;17(4):225-226. doi: 10.1038/s41581-020-00379-y. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |