Clinical trial NCT05083026: Neutralizing Antibody Level After COVID-19 Vaccination
Official title: Neutralizing Antibody Level After COVID-19 Vaccination in Hospital Works.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthcare works aged 20-60 years after completion of COVID-19 vaccination

participants have no serious disease.

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* serious underlying diseases

Primary outcomes:
measure: titer of neutralizing antibody after COVID-19 vaccination
timeFrame: at 2month after COVID-19 vaccination
measure: titer of neutralizing antibody after COVID-19 vaccination
timeFrame: at 4 month after COVID-19 vaccination
measure: titer of neutralizing antibody after COVID-19 vaccination
timeFrame: at 6 month after COVID-19 vaccination
measure: titer of neutralizing antibody after COVID-19 vaccination
timeFrame: at 9 month after COVID-19 vaccination
measure: titer of neutralizing antibody after COVID-19 vaccination
timeFrame: at 12 month after COVID-19 vaccination
measure: body weight (Kg)
timeFrame: at 2 month after COVID-19 vaccination
measure: body mass index (kg/m^2)
timeFrame: at 2 month after COVID-19 vaccination
measure: Compare 4 diagnostic ELISA kit after COVID-19 vaccination
timeFrame: at 2 month after COVID-19 vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Su Youn Nam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nam SY, Jeon SW, Jung DK, Heo SJ. Body Weight is Inversely Associated with Anti-SARS-CoV-2 Antibody Levels after BNT162b2 mRNA Vaccination in Young and Middle Aged Adults. Infect Chemother. 2022 Sep;54(3):504-516. doi: 10.3947/ic.2022.0089.