COVID-19 Vaccine Reactogenicity and Immunogenicity

Predictive Value of Reactogenicity for Anti-SARS-CoV-2 Antibody Response in mRNA-1273 Recipients: a Multicenter Prospective Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Vaccine Adverse Reaction; Vaccine Immune Response
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 179

Contacts and Locations

• Study Contact: Name: Joon Young Song; Phone Number: +82226263052; Email: infection@korea.ac.kr
• Study Contact Backup: Name: Min Joo Choi; Phone Number: 82226262462; Email: cowgow@naver.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Catholic Kwandong University
    • Contact: Min Joo Choi; Phone Number: 821041156525
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Young Kyung Yoon
  • Seoul, Korea, Republic of
    • Recruiting
    • KangNam Sacred Heart Hospital
    • Contact: Yu Bin Seo
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital
    • Contact: Joon Young Song; Email: infection@korea.ac.kr
    • Contact: Seung Hoe Song; Phone Number: 82226261635; Email: ssesong@korea.ac.kr
  • Suwon, Korea, Republic of
    • Recruiting
    • Ajou University School of Medicine Hallym University
    • Contact: Jung Yeon Heo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy young adults between the ages of 19 and 55 years who were willing to receive the mRNA-1273 vaccine were enrolled in the study and provided written informed consent

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between humoral immune response and reactogenicity after vaccination	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-SARS-CoV-2 antibody	SARS-CoV-2 immunoglobulin G (IgG) assay (Abbott Laboratories, Chicago, IL, USA)	before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
neutralizing antibody titer	plaque reduction neutralization test was performed using wild-type SARS-CoV-2 virus (BetaCoV/Korea/KCDC03/2020)	before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
reactogenicity after vaccination	record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire	Seven days after each dose of vaccine
Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer	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)	At 3 months and 6 months after dose 1

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Korea University Anam Hospital; Ajou University School of Medicine; Korean Center for Disease Control and Prevention; Hallym University Kangnam Sacred Heart Hospital; Catholic Kwandong University
• Investigators: Principal Investigator: Joon Young Song, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021GR0274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.

Drug and device information, study documents

• 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