Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine (ROMANOV)
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|ClinicalTrials.gov Identifier: NCT04881396|
Recruitment Status : Completed
First Posted : May 11, 2021
Last Update Posted : May 10, 2022
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.
|Condition or disease||Intervention/treatment|
|COVID-19 Vaccines Hemodialysis Complication||Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine|
|Actual Study Start Date :||May 10, 2021|
|Actual Primary Completion Date :||February 15, 2022|
|Actual Study Completion Date :||February 15, 2022|
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).
Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients
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)
- Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine [ Time Frame: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose. ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881396
|Department of Nephrology, Hopital Edouard Herriot|
|Lyon, France, 69003|
|Department of Nephrology, Centre Hospitalier Lyon Sud|
|Pierre Bénite, France, 69495|