Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine (ROMANOV)

Civil Hospices of Lyon

Status: Completed

Conditions: Hemodialysis Complication; COVID-19 Vaccines

Treatments: Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients

Study type: Observational

Funder types: Other

Identifiers

NCT04881396

69HCL21_0125

2021-A00325-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 1 patient group

All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine

Description:

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).

Treatment:

Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients