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Completed

NCT Number: NCT04728828

COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Quimper

Quimper, 29000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serological COVID-19 vaccine immunogenicity

Biological

Serological test

Primary outcomes

  1. antibody synthesis induced after Covid-19 vaccination (positive or negative)

    Time frame: 1 month after 2nd injection

    evaluation of IgG anti-S level

Secondary outcomes

  1. Lack of immunogenicity

    Time frame: 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

  2. COVID-19 incidence

    Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months

  3. Death during follow up

    Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months

  4. 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)

    Time frame: 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

  5. Longevity of the antibody synthesis induced after Covid-19 vaccination

    Time frame: 3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection

    evaluation of IgG anti-S level

  6. antibody synthesis induced after one injection of Covid-19 vaccine

    Time frame: before second injection

    evaluation of IgG anti-S level

Other outcomes

  1. Hepatitis B-vaccination response

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cornouaille

Other

Collaborators

  • Centre Hospitalier Régional et Universitaire de Brest

Registry information

Official study title

Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France

Acronym: COVADIAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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