COVID-19 Vaccine Reactogenicity and Immunogenicity

• Conditions: COVID-19; Vaccine Adverse Reaction; Vaccine Immune Response

• Registration Number: NCT05258708
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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

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 Timeline

• Study Start: 2021-06-24
• Status Verified: 2022-02
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
reactogenicity after vaccination	Seven days after each dose of vaccine	record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire

Trial Locations

Locations (5)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Catholic Kwandong University; 🇰🇷 Incheon, Korea, Republic of

Ajou University School of Medicine Hallym University; 🇰🇷 Suwon, Korea, Republic of

Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

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