RecruitingNCT05083026Updated Oct 4, 2023

Neutralizing Antibody Level After COVID-19 Vaccination

An observational study in Covid19, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Kyungpook National University Hospital · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 51
Ages: 20 Years to 60 Years
Sex: All

Study summary

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

Read the detailed description

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)
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
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

Conditions studied

Covid19

Browse trials for

COVID-19 7,633

Who can participate

Ages eligible: 20 Years to 60 Years
Sexes eligible: All
Sampling method: Non-probability sample

Study population

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

participants have no serious disease.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

serious underlying diseases

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 51 participants (estimated)
Patient registry: No
Biospecimen retention: Samples without dna

Interventions

Diagnostic testCOVID-19 neutralizing antibody
This study enrolled persons already who received COVID-19 vaccination under government policy. 1. We collect 5mL blood at 2, 4, 6, 9, 12 months after COVID-19 vaccination 2. isolate serum and store in -80 degree deep freezer 3. measure neutralizing Antibody

What researchers measure

Primary outcomes

titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Time frame: at 2month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Time frame: at 4 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Time frame: at 6 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Time frame: at 9 month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Time frame: at 12 month after COVID-19 vaccination
body weight (Kg)
correlation between antibody titer and body weight: spearmann's correlation
Time frame: at 2 month after COVID-19 vaccination
body mass index (kg/m^2)
correlation between antibody titer and body weight: spearmann's correlation
Time frame: at 2 month after COVID-19 vaccination
Compare 4 diagnostic ELISA kit 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
Time frame: at 2 month after COVID-19 vaccination

Study locations

1 of 1 sites recruiting

Kyungpook National University Hospital
Daegu, 41404, Korea, Republic of
- Su Youn Nam, MD, PhD · Contact · nam20131114@gmail.com · 82-53-200-2610
Recruiting

References and documents

Publications

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. PubMed 36196609 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT05083026
Lead sponsor: Kyungpook National University Hospital
Responsible party: Su Youn Nam (Assistant professor, Kyungpook National University Hospital) — Principal investigator
First posted: Oct 19, 2021
Start date: Jun 2, 2021
Primary completion: Dec 31, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Oct 4, 2023

Study contacts

Su Youn Nam, MD, PhD

Contact

nam20131114@gmail.com

82-53-200-2610

Su Youn Nam, MD, PhD

principal investigator · Kyungpook National University Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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