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Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

NCT04881396 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2022-05-10

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881396 on ClinicalTrials.gov