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NCT05083026 Clinical Trial

Neutralizing Antibody Level After COVID-19 Vaccination

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05083026
Other study ID # KNUCH-2021005-001-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2, 2021
Est. completion date December 31, 2024

Study information
Verified date October 2023
Source Kyungpook National University Hospital
Contact Su Youn Nam, MD, PhD
Phone 82-53-200-2610
Email nam20131114@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 51
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - healthcare works after completion of COVID-19 vaccination - 20-60 years - sign the agreement of study Exclusion Criteria: - serious underlying diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• COVID-19 neutralizing antibody
This study enrolled persons already who received COVID-19 vaccination under government policy. We collect 5mL blood at 2, 4, 6, 9, 12 months after COVID-19 vaccination isolate serum and store in -80 degree deep freezer measure neutralizing Antibody

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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