ClinicalTrials.gg
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

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
51
Ages
20 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 89 studies in COVID-19 with a site in Korea, Republic of — 10 open to participants now, 18 under way, 6 of them phase 3. COVID-19 · Korea, Republic of.

Planned enrollment
16th of 18
51 · median 730
Started
2021
with 28 others
Observational
18 of 89
2 open now
Primary completion
2024-12
later than 1 of 17 live
Registered
47th of 89
by date

Among the 89 studies in COVID-19 with a site in Korea, Republic of, this one is the 16th largest by planned enrollment of the 18 observational ones that give a count, is one of 29 that started in 2021, is one of 18 observational ones, reaches primary completion later than 1 of the 17 other live ones, and was the 47th registered.

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

10 of the 89 studies in COVID-19 with a site in Korea, Republic of are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.

This study: 20 Years to 60 Years · all sexes.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 89 studies in COVID-19 with a site in Korea, Republic of, or all of them as a file.
02

Study summary

  1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination
  2. investigate the factors on antibody titer.
Read the 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
03

Conditions studied

  • Covid19

Browse trials for

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. body weight (Kg)

    correlation between antibody titer and body weight: spearmann's correlation

    Time frame: at 2 month after COVID-19 vaccination

  7. 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

  8. 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

07

Study locations

1 of 1 sites recruiting
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Dec 2024, 42 months after the start.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 42 months is above that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2021
First posted
Oct 19, 2021
StartActual
Jun 2, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Oct 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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