Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Hemodialysis Complication Clinical Trial

— ROMANOV  

Official title:

Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881396
• Other study ID #: 69HCL21_0125
• Secondary ID: 2021-A00325-36
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Vaccines
• Hemodialysis Complication

Intervention

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)

Locations

Country	Name	City	State
France	Department of Nephrology, Hopital Edouard Herriot	Lyon
France	Department of Nephrology, Centre Hospitalier Lyon Sud	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.