COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?

Official Title
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Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France

Conditions
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Covid19

Intervention / Treatment
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* Biological: Serological COVID-19 vaccine immunogenicity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all in-center haemodialysis individuals eligible and voluntary to receive one of the approved COVID-19 vaccines. Exclusion Criteria: individuals under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination<br> | Biological: Serological COVID-19 vaccine immunogenicity<br>* Serological test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Vaccine response, Serology, haemodialysis