Covid19
Conditions
Keywords
Covid19, Vaccine response, Serology, haemodialysis
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?
Interventions
BIOLOGICALSerological COVID-19 vaccine immunogenicity
Serological test
Sponsors
Centre Hospitalier de Cornouaille
Centre Hospitalier Régional et Universitaire de Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| antibody synthesis induced after Covid-19 vaccination (positive or negative) | 1 month after 2nd injection | evaluation of IgG anti-S level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lack of immunogenicity | day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months | evaluation of IgG anti-S level |
| 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 | — |
| 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 | evaluation of IgG anti-S level |
| antibody synthesis induced after one injection of Covid-19 vaccine | before second injection | evaluation of IgG anti-S level |
| 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 | evaluation of IgG anti-S level |
Other
| Measure | Time frame |
|---|---|
| Hepatitis B-vaccination response | Day 0 |
Countries
France
Outcome results
None listed