Covid19NCT05083026
Neutralizing Antibody Level After COVID-19 Vaccination
An observational study of Covid19, run by Kyungpook National University Hospital at 1 site in South Korea.
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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
Study population: healthcare works aged 20-60 years after completion of COVID-19 vaccination participants have no serious disease.
Who may be able to join
- healthcare works after completion of COVID-19 vaccination
- 20-60 years
- sign the agreement of study
Who cannot join
- serious underlying diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41404
Su Youn Nam, MD, PhD, 82-53-200-2610, nam20131114@gmail.com
About this study
Official title: Neutralizing Antibody Level After COVID-19 Vaccination in Hospital Works.
- 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
- Covid19
- Being tested
- COVID-19 neutralizing antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 neutralizing antibodyDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Measured: at 2month after COVID-19 vaccination
titer of neutralizing antibody after COVID-19 vaccination
semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination
Measured: 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
Measured: 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
Measured: 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
Measured: at 12 month after COVID-19 vaccination
body weight (Kg)
correlation between antibody titer and body weight: spearmann's correlation
Measured: at 2 month after COVID-19 vaccination
body mass index (kg/m^2)
correlation between antibody titer and body weight: spearmann's correlation
Measured: at 2 month after COVID-19 vaccination
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
Measured: at 2 month after COVID-19 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start2 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Youn Nam, Kyungpook National University Hospital
- Investigators
- Su Youn Nam, MD, PhD, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083026
- Sponsor's protocol ID
- KNUCH-2021005-001-001
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutralizing Antibody Level After COVID-19 Vaccination in Hospital Works.
- ClinicalTrials.gov ID
- NCT05083026
- Acronym / sponsor ID
- KNUCH-2021005-001-001
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination
- investigate the factors on antibody titer.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- healthcare works aged 20-60 years after completion of COVID-19 vaccination participants have no serious disease.
Key inclusion criteria (3 listed)
- healthcare works after completion of COVID-19 vaccination
- 20-60 years
- sign the agreement of study
Key exclusion criteria (1 listed)
- serious underlying diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 neutralizing antibodyThis 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 | Diagnostic test | – |
Primary outcome
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
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
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
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
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
body weight (Kg)
Time frame: at 2 month after COVID-19 vaccination
correlation between antibody titer and body weight: spearmann's correlation
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 36196609Nam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Youn Nam, MD, PhD principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Youn Nam, MD, PhD (82-53-200-2610, nam20131114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
titer of neutralizing antibody after COVID-19 vaccination (time frame: at 2month after COVID-19 vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.