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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04881396
Recruitment Status : Completed
First Posted : May 11, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
COVID-19 Vaccines Hemodialysis Complication Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
Actual Study Start Date : May 10, 2021
Actual Primary Completion Date : February 15, 2022
Actual Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine
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).
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)




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2 mRNA Cov-19 with classical scheme
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881396


Locations
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France
Department of Nephrology, Hopital Edouard Herriot
Lyon, France, 69003
Department of Nephrology, Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04881396    
Other Study ID Numbers: 69HCL21_0125
2021-A00325-36 ( Other Identifier: ID-RCB )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
immunogenicity
haemodialysis patients
SARS-Cov2 vaccine