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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04881396

Collaborator

(none)

Enrollment

Locations

9.2

Actual Duration (Months)

49.5

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
COVID-19 Vaccines Hemodialysis Complication	Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients

Study Design

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 :

Feb 15, 2022

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology, Hopital Edouard Herriot	Lyon		France	69003
2	Department of Nephrology, Centre Hospitalier Lyon Sud	Pierre Bénite		France	69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04881396

Other Study ID Numbers:

69HCL21_0125
2021-A00325-36

First Posted:

May 11, 2021

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

immunogenicity

haemodialysis patients

SARS-Cov2 vaccine

Study Results

No Results Posted as of May 10, 2022