Neutralizing Antibody Level After COVID-19 Vaccination

October 3, 2023 updated by: Su Youn Nam, Kyungpook National University Hospital

Neutralizing Antibody Level After COVID-19 Vaccination in Hospital Works.

  1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination
  2. investigate the factors on antibody titer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination 1) semi-quantitative measurement of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination 2) investigate the duration maintaining acceptable range (over 30% inhibition)
  2. investigate the factors on antibody titer at 2 month after vaccination 1) potential factors: age, sex, body weight, height, use of medication, use of antipyretics (NSAID or tyrenol), side effect of COVID-19 vaccination 2) correlation between antibody titer and potential factors
  3. Compare 4 diagnostic ELISA kit at 2 month after vaccination 1) measure neutralizung antibody using ELISA kits from 4 different companies 2) investigate correlation coefficient of antibody titer between companies

Study Type

Observational

Enrollment (Estimated)

51

Contacts and Locations

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

Study Contact

Study Locations

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

healthcare works aged 20-60 years after completion of COVID-19 vaccination

participants have no serious disease.

Description

Inclusion Criteria:

  • healthcare works after completion of COVID-19 vaccination
  • 20-60 years
  • sign the agreement of study

Exclusion Criteria:

  • serious underlying diseases

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
titer of neutralizing antibody after COVID-19 vaccination
Time Frame: at 2month after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
at 2month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
Time Frame: at 4 month after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
at 4 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
Time Frame: at 6 month after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
at 6 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
Time Frame: at 9 month after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
at 9 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
Time Frame: at 12 month after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
at 12 month after COVID-19 vaccination
body weight (Kg)
Time Frame: at 2 month after COVID-19 vaccination
correlation between antibody titer and body weight: spearmann's correlation
at 2 month after COVID-19 vaccination
body mass index (kg/m^2)
Time Frame: at 2 month after COVID-19 vaccination
correlation between antibody titer and body weight: spearmann's correlation
at 2 month after COVID-19 vaccination
Compare 4 diagnostic ELISA kit after COVID-19 vaccination
Time Frame: at 2 month after COVID-19 vaccination
  1. measure neutralizung antibody using ELISA kits from 4 different companies 2 months after COVID-19 vaccination
  2. investigate correlation coefficient of antibody titer between companies
at 2 month after COVID-19 vaccination

Collaborators and Investigators

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

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Su Youn Nam, MD, PhD, Kyungpook National University Hospital

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

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)

June 2, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 8, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUCH-2021005-001-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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