NCT04881396

Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Vaccines
• Hemodialysis Complication

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-02-15
• Completion: 2022-02-15
• First posted: 2021-05-11
• Last updated: 2022-05-10

Locations

2 sites across 1 country: France