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

August 4, 2022 updated by: GUILLERMO JAVIER ROSA DIEZ, Hospital Italiano de Buenos Aires
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Caba
      • Buenos Aires, Caba, Argentina, 1121A6B
        • Universidad de Buenos Aires Facultad de Medicina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients in an immunization plan with a COVID-19 vaccine from the hemodialysis centers of the Autonomous City of Buenos Aires

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
Time Frame: 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
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
Time Frame: 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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

University of Buenos Aires
Ministerio de Salud de Ciudad Autónoma de Buenos Aires

Investigators

  • Principal Investigator: Guillermo IP Rosa Diez, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Jorge SI Geffner, University of Buenos Aires
  • Study Chair: Fernando SI Lombi, Sociedad Argentina de Nefrología
  • Study Chair: Marina SI Papaginovic, Sociedad Argentina de Nefrología
  • Study Chair: Ricardo SI Heguilen, Sociedad Argentina de Nefrología
  • Study Chair: Luciana Fernandez SI Paganti, Sociedad Argentina de Nefrología
  • Study Chair: Soledad SI Crucelegui, Hospital Italiano de Buenos Aires
  • Study Chair: Vanina SI Pagotto, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

August 4, 2022

Study Completion (Actual)

August 4, 2022

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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