Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Completed

• Conditions: COVID-19 Vaccines; Hemodialysis Complication
• Interventions: Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients

• Registration Number: NCT04881396
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-04
• Study Start: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Medical prescription of BTN162b2 mRNA Cov-19 vaccine
• Treatment by chronic (>1 month) haemodialysis

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Exclusion Criteria

• Non-recommended vaccination scheme
• Refusal to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine	Evaluation of the immunogenicity of the vaccine in haemodialysis patients	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).

Primary Outcome Measures

Name	Time	Method
Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine	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.

Trial Locations

Locations (2)

Department of Nephrology, Hopital Edouard Herriot; 🇫🇷 Lyon, France

Department of Nephrology, Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France