Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Study Overview
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Brief Summary
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Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients. The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.

Official Title
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Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Conditions
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COVID-19 Vaccines, Hemodialysis Complication

Intervention / Treatment
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* Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical prescription of BTN162b2 mRNA Cov-19 vaccine Treatment by chronic (>1 month) haemodialysis Exclusion Criteria: Non-recommended vaccination scheme Refusal to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine<br>Serological response is defined by a 4 fold increase of IgG anti-spike protein of SARS-Cov2 between Day 0 (before vaccination) and after complete vaccination (evaluated at Day 7 - 14 post-boost). | Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients<br>* The immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine | IgG anti SARS-Cov2 spike protein will be evaluated by ELISA at Day 0 (at the initiation of vaccination) anti Day 7 - Day 14 after the second dose (peak of response). The seroconversion is defined by an 4 fold increase of IgG anti SARS-Cov2 spike protein titer between Day 0 and Day 7 - Day 14 after second dose. | The seroconversion rate is evaluated at Day 7-Day 14 after the second dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunogenicity, haemodialysis patients, SARS-Cov2 vaccine