COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

Completed

• Conditions: Covid19
• Interventions: Biological: Serological COVID-19 vaccine immunogenicity

• Registration Number: NCT04728828
• Lead Sponsor: Centre Hospitalier de Cornouaille

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?

Study Timeline

• Study Start: 2021-01-25
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Primary Completion: 2023-01-15
• Study Completion: 2023-08-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination	Serological COVID-19 vaccine immunogenicity	-

Primary Outcome Measures

Name	Time	Method
antibody synthesis induced after Covid-19 vaccination (positive or negative)	1 month after 2nd injection	evaluation of IgG anti-S level

Secondary Outcome Measures

Name	Time	Method
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	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
antibody synthesis induced after one injection of Covid-19 vaccine	before second injection	evaluation of IgG anti-S level
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

Trial Locations

Locations (1)

Centre Hospitalier de Quimper; 🇫🇷 Quimper, France