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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00325-36 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of the immunogenicity of the vaccine in haemodialysis patients | Biological | 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2 mRNA Cov-19 with classical scheme
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Hopital Edouard Herriot | Lyon | 69003 | France | |||
| Department of Nephrology, Centre Hospitalier Lyon Sud |
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| Pierre-Bénite |
| 69495 |
| France |