Clinical trial NCT04728828: COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients
Official title: Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Vaccine response
Serology
haemodialysis
Lead sponsor: Centre Hospitalier de Cornouaille
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Régional et Universitaire de Brest
First posted: 2021-01-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all in-center haemodialysis patients eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.

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?

Eligibility criteria: 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

Primary outcomes:
measure: antibody synthesis induced after Covid-19 vaccination (positive or negative)
timeFrame: 1 month after 2nd injection
Secondary outcomes:
measure: Lack of immunogenicity
timeFrame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure: COVID-19 incidence
timeFrame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure: Death during follow up
timeFrame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure: 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)
timeFrame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure: Longevity of the antibody synthesis induced after Covid-19 vaccination
timeFrame: 3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection
measure: antibody synthesis induced after one injection of Covid-19 vaccine
timeFrame: before second injection
Other outcomes:
measure: Hepatitis B-vaccination response
timeFrame: Day 0
Locations:
city: Quimper
country: France
facility: Centre Hospitalier de Quimper
Study officials:
References:
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. 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.
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.
citation: 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.
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.