NCT05083026

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

August 8, 2021

Last Update Submit

October 3, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

  • titer of neutralizing antibody after COVID-19 vaccination

    semi-quantitative measurement of neutralizing antibody after COVID-19 vaccination

    at 2month after COVID-19 vaccination

  • 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

  • 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

  • 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

  • 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

  • body weight (Kg)

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

    at 2 month after COVID-19 vaccination

  • body mass index (kg/m^2)

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

    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

    at 2 month after COVID-19 vaccination

Interventions

COVID-19 neutralizing antibodyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthcare works aged 20-60 years after completion of COVID-19 vaccination participants have no serious disease.

You may qualify if:

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

You may not qualify if:

  • serious underlying diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41404, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36196609DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. 5mL blood at 2, 4, 6, 9, 12 months after COVID-19 vaccination. 2. centrifuge and get serum sample 3. store at -80 degree deep freezer until use

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Su Youn Nam, MD, PhD

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Youn Nam, MD, PhD

CONTACT

82-53-200-2610nam20131114@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 8, 2021

First Posted

October 19, 2021

Study Start

June 2, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)