COVID-19, Vaccine Adverse Reaction, Vaccine Immune Response
Conditions
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.
Interventions
BIOLOGICALmRNA-1273 COVID-19 vaccine
two doses of mRNA-1273 vaccine at 28-day intervals
Sponsors
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
Korea University Guro Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| reactogenicity after vaccination | Seven days after each dose of vaccine | record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire |
| 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) |
Countries
South Korea
Contacts
Primary ContactJoon Young Song
Backup ContactMin Joo Choi
Outcome results
None listed