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NCT04881396: ROMANOV

Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Completed Last updated 10 May 2022
What this trial tests

trial testing Evaluation of the immunogenicity of the vaccine in haemodialysis patients in COVID-19 Vaccines in 99 participants. Completed in 15 February 2022.

Timeline
10 May 2021
Primary endpoint
15 February 2022
15 February 2022

Quick facts

Lead sponsorHospices Civils de Lyon
StatusCompleted
Study typeOBSERVATIONAL
Enrollment99
Start date10 May 2021
Primary completion15 February 2022
Estimated completion15 February 2022
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 130, any sex, with COVID-19 Vaccines or Hemodialysis Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A prospective observational study for justification, safety, and efficacy of a third dose of mRNA vaccine in patients receiving maintenance hemodialysis.
    Espi M, Charmetant X, Barba T, Mathieu C, et al · · 2022 · cited 72× · PMID 34856313 · DOI 10.1016/j.kint.2021.10.040
  2. SARS-CoV-2 vaccination in patients receiving kidney replacement therapies: where are we now with the protective immune response?
    Toapanta N, Bestard O, Soler MJ. · · 2021 · cited 5× · PMID 34289072 · DOI 10.1093/ndt/gfab227
  3. Justification, safety, and efficacy of a third dose of mRNA vaccine in maintenance hemodialysis patients: a prospective observational study
    Espi M, Charmetant X, Barba T, Pelletier C, et al · · 2021 · cited 2× · DOI 10.1101/2021.07.02.21259913

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Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04881396.

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