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NCT05258708 Clinical Trial

COVID-19 Vaccine Reactogenicity and Immunogenicity

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05258708
Other study ID # 2021GR0274
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2021
Est. completion date May 30, 2022

Study information
Verified date February 2022
Source Korea University Guro Hospital
Contact Joon Young Song
Phone +82226263052
Email infection@korea.ac.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 179
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• mRNA-1273 COVID-19 vaccine
two doses of mRNA-1273 vaccine at 28-day intervals

Locations
Country Name City State
Korea, Republic of Catholic Kwandong University Incheon
Korea, Republic of Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Korea University Anam 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 Ajou University School of Medicine Hallym University Suwon

Sponsors (6)
Lead Sponsor Collaborator
Korea University Guro Hospital Ajou University School of Medicine, Catholic Kwandong University, Hallym University Kangnam Sacred Heart Hospital, Korea University Anam Hospital, Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary reactogenicity after vaccination record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire Seven days after each dose of vaccine
Secondary 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
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