Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04881396

Acronym

ROMANOV

Enrollment

Registered

2021-05-11

Start date

2021-05-10

Completion date

2022-02-15

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccines, Hemodialysis Complication

Keywords

immunogenicity, haemodialysis patients, SARS-Cov2 vaccine

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.

Interventions

BIOLOGICALEvaluation 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)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026