Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

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.

Completed

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Key information

Conditions

COVID-19 Vaccines Hemodialysis Complication

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology, Hopital Edouard Herriot, Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the immunogenicity of the vaccine in haemodialysis patients

Biological

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)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ROMANOV

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 11, 2021
Registry last updated: May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed