COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

NCT04728828 | Completed DMC

• 1 other identifier: COVADIAL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; Vaccine response; Serology; haemodialysis

Outcome Measures

Primary Outcomes (1)

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

  evaluation of IgG anti-S level

  1 month after 2nd injection

Secondary Outcomes (6)

• Lack of immunogenicity

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

• COVID-19 incidence

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

• Death during follow up

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

• 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

• 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

Other Outcomes (1)

• Hepatitis B-vaccination response

  Day 0

Study Arms (1)

In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination

Biological: Serological COVID-19 vaccine immunogenicity

Interventions

Serological COVID-19 vaccine immunogenicity BIOLOGICAL

Serological test

In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all in-center haemodialysis patients eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.

You may qualify if:

• all in-center haemodialysis individuals eligible and voluntary to receive one of the approved COVID-19 vaccines.

You may not qualify if:

• individuals under 18 years of age

Sponsors & Collaborators

• Centre Hospitalier de Cornouaille: lead
• Centre Hospitalier Régional et Universitaire de Brest: collaborator

Study Sites (1)

Centre Hospitalier de Quimper

Quimper, 29000, France

Location

Related Publications (4)

• Jager KJ, Kramer A, Chesnaye NC, Couchoud C, Sanchez-Alvarez JE, Garneata L, Collart F, Hemmelder MH, Ambuhl P, Kerschbaum J, Legeai C, Del Pino Y Pino MD, Mircescu G, Mazzoleni L, Hoekstra T, Winzeler R, Mayer G, Stel VS, Wanner C, Zoccali C, Massy ZA. Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe. Kidney Int. 2020 Dec;98(6):1540-1548. doi: 10.1016/j.kint.2020.09.006. Epub 2020 Oct 15.

  PMID: 32979369 RESULT

• ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.

  PMID: 33340043 RESULT

• Eleftheriadis T, Antoniadi G, Liakopoulos V, Kartsios C, Stefanidis I. Disturbances of acquired immunity in hemodialysis patients. Semin Dial. 2007 Sep-Oct;20(5):440-51. doi: 10.1111/j.1525-139X.2007.00283.x.

  PMID: 17897251 RESULT

• Mahalingasivam V, Tomlinson L. The seroprevalence of SARS-CoV-2 in patients on haemodialysis. Nat Rev Nephrol. 2021 Apr;17(4):225-226. doi: 10.1038/s41581-020-00379-y.

  PMID: 33230249 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: January 25, 2021
• Primary Completion: January 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

FR (1)