Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis

NCT04871945 | Completed

• 1 other identifier: 2021-02-033
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.

Conditions

Covid19; Vaccine Reaction; Hemolysis; End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• The change in the level of neutralizing antibody against SARS-CoV-2

  Day 0, 14, 28, 56, 91, 120

Interventions

Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA) DIAGNOSTIC_TEST

The antibody level will be measured by the above mentioned methods. The trial drugs are not used but the vaccine that included in National Immunization Program for COVID-19 in Korea will be used for the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients group : Patients under hemodialysis Control group : Healthy population

You may qualify if:

• The person who is vaccinated with ChAdOx1 (COVID-19 vaccine)
• The person who agrees with the protocol of the study

You may not qualify if:

• Age \< 18 years
• Pregnants
• Experience of COVID-19 infection

Sponsors & Collaborators

• Hanyang University Seoul Hospital: lead
• Seegene Medical Foundation: collaborator

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, South Korea

Location

Related Publications (1)

• Park JS, Minn D, Hong S, Jeong S, Kim S, Lee CH, Kim B. Immunogenicity of COVID-19 Vaccination in Patients With End-Stage Renal Disease Undergoing Maintenance Hemodialysis: The Efficacy of a Mix-and-Match Strategy. J Korean Med Sci. 2022 Jun 13;37(23):e180. doi: 10.3346/jkms.2022.37.e180.

  PMID: 35698835 DERIVED

MeSH Terms

Conditions

COVID-19; Hemolysis; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: April 20, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: March 17, 2022

Record last verified: 2021-03

Locations

KR (1)