COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients

Covid19 Clinical Trial

— COVADIAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04728828
• Other study ID #: COVADIAL
• Status: Active, not recruiting
• Start date: January 25, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier de Cornouaille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Serological COVID-19 vaccine immunogenicity
Serological test

Locations

Country	Name	City	State
France	Centre Hospitalier de Quimper	Quimper

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Cornouaille	Centre Hospitalier Régional et Universitaire de Brest

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. R — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hepatitis B-vaccination response		Day 0
Primary	antibody synthesis induced after Covid-19 vaccination (positive or negative)	evaluation of IgG anti-S level	1 month after 2nd injection
Secondary	Lack of immunogenicity	evaluation of IgG anti-S level	day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Secondary	COVID-19 incidence		day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Secondary	Death during follow up		day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Secondary	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)	evaluation of IgG anti-S level	day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Secondary	Longevity of the antibody synthesis induced after Covid-19 vaccination	evaluation of IgG anti-S level	3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection
Secondary	antibody synthesis induced after one injection of Covid-19 vaccine	evaluation of IgG anti-S level	before second injection