Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Centre Hospitalier de Cornouaille
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- antibody synthesis induced after Covid-19 vaccination (positive or negative)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
antibody synthesis induced after Covid-19 vaccination (positive or negative)
Time Frame: 1 month after 2nd injection
evaluation of IgG anti-S level
Secondary Outcomes
- COVID-19 incidence(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- Lack of immunogenicity(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)(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- antibody synthesis induced after one injection of Covid-19 vaccine(before second injection)
- Death during follow up(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(3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection)