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COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

NCT04728828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-08-20

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Serological COVID-19 vaccine immunogenicity

Serological test

Sponsors & Collaborators

  • Centre Hospitalier Régional et Universitaire de Brest

    collaborator OTHER

  • Centre Hospitalier de Cornouaille

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-01-15
Completion
2023-08-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728828 on ClinicalTrials.gov