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?
Study Type
OBSERVATIONAL
Enrollment
500
Serological test
Centre Hospitalier de Quimper
Quimper, France
antibody synthesis induced after Covid-19 vaccination (positive or negative)
evaluation of IgG anti-S level
Time frame: 1 month after 2nd injection
Lack of immunogenicity
evaluation of IgG anti-S level
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
COVID-19 incidence
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Death during follow up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before second injection
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