Trials / Completed
CompletedNCT04728828
COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients
Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Centre Hospitalier de Cornouaille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Serological COVID-19 vaccine immunogenicity | Serological test |
Timeline
- Start date
- 2021-01-25
- Primary completion
- 2023-01-15
- Completion
- 2023-08-15
- First posted
- 2021-01-28
- Last updated
- 2024-08-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04728828. Inclusion in this directory is not an endorsement.