Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

Completed

• Conditions: Renal Dialysis; Coronavirus Disease 2019 Vaccines

• Registration Number: NCT04944433
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. Objectives: To evaluate the safety and efficacy of Coronavirus disease 2019 vaccines in hemodialysis patients.

Detailed Description

Given the vulnerability of people with chronic kidney disease to Coronavirus 2019 , leading nephrology societies such as the National Kidney Federation and the American Kidney Foundation have issued statements calling for prioritization of these patients for vaccination. It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy.

Objectives:

1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine

2. Determine the levels of Immunoglobulin G antibodies in patients who received a Coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization.

Methods Design: Multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a Coronavirus disease 2019 vaccine in the Autonomous City of Buenos Aires in a vaccination plan.

Analysis The proportion of patients with Adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. The immunoglobulin G titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using Generalized Estimating Equations models.

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Status Verified: 2022-08
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

• Patients over 18 years of age on hemodialysis in an immunization plan with a Coronavirus disease 2019 vaccine.

Exclusion Criteria

• Contraindication to receive the vaccine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine	one year	Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization	one year	To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization

Trial Locations

Locations (1)

Universidad de Buenos Aires Facultad de Medicina; 🇦🇷 Buenos Aires, Caba, Argentina