COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

  • STATUS
    Recruiting
  • End date
    Aug 15, 2023
  • participants needed
    500
  • sponsor
    Centre Hospitalier de Cornouaille
Updated on 4 March 2021

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.

Description

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

Details
Condition COVID19
Treatment Serological COVID-19 vaccine immunogenicity
Clinical Study IdentifierNCT04728828
SponsorCentre Hospitalier de Cornouaille
Last Modified on4 March 2021

Eligibility

Yes No Not Sure

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
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