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COVID-19 Vaccine Reactogenicity and Immunogenicity

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05258708
Collaborator
Catholic Kwandong University (Other), Ajou University School of Medicine (Other), Hallym University Kangnam Sacred Heart Hospital (Other), Korea University Anam Hospital (Other), Korean Center for Disease Control and Prevention (Other)
179
Enrollment
5
Locations
11.2
Anticipated Duration (Months)
35.8
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1273 COVID-19 vaccine

Detailed Description

We conducted a prospective study on healthy young adults who were to receive two doses of mRNA-1273 vaccine at 28-day intervals. After each dose, adverse events were prospectively evaluated, and blood samples were collected. The correlation between humoral immune response and reactogenicity after vaccination was determined. In addition, long-term anti-SARS-CoV-2 antibody kinetics will be assessed.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
179 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Reactogenicity for Anti-SARS-CoV-2 Antibody Response in mRNA-1273 Recipients: a Multicenter Prospective Cohort Study
Actual Study Start Date :
Jun 24, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
May 30, 2022

Outcome Measures

Primary Outcome Measures

  1. The correlation between humoral immune response and reactogenicity after vaccination [The correlation between reactogenicity after dose 1 and immunogenicity at T1 (28 days after dose 1 prior to the 2nd dose) and T2 (28 days after dose 2); the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2]

    The correlation between humoral immune response and reactogenicity after vaccination

Secondary Outcome Measures

  1. anti-SARS-CoV-2 antibody [before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)]

    SARS-CoV-2 immunoglobulin G (IgG) assay (Abbott Laboratories, Chicago, IL, USA)

  2. neutralizing antibody titer [before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)]

    plaque reduction neutralization test was performed using wild-type SARS-CoV-2 virus (BetaCoV/Korea/KCDC03/2020)

  3. reactogenicity after vaccination [Seven days after each dose of vaccine]

    record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire

  4. Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer [At 3 months and 6 months after dose 1]

    SARS-CoV-2 immunoglobulin G (IgG) assay (Abbott Laboratories, Chicago, IL, USA); plaque reduction neutralization test was performed using wild-type SARS-CoV-2 virus (BetaCoV/Korea/KCDC03/2020)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • who were willing to receive the mRNA-1273 vaccine
Exclusion Criteria:

  • previously diagnosed with laboratory-confirmed COVID-19

  • history of autoimmune disease

  • immunocompromised, pregnant, or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catholic Kwandong University Incheon Korea, Republic of
2 Kangnam Sacred Heart Hospital Seoul Korea, Republic of
3 Korea University Anam Hospital Seoul Korea, Republic of
4 Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital Seoul Korea, Republic of
5 Ajou University School of Medicine Hallym University Suwon Korea, Republic of

Sponsors and Collaborators

  • Korea University Guro Hospital
  • Catholic Kwandong University
  • Ajou University School of Medicine
  • Hallym University Kangnam Sacred Heart Hospital
  • Korea University Anam Hospital
  • Korean Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Joon Young Song, Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joon Young Song, MD, PhD, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT05258708
Other Study ID Numbers:
  • 2021GR0274
First Posted:
Feb 28, 2022
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Feb 28, 2022