Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Catholic Kwandong University | OTHER |
| Ajou University School of Medicine | OTHER |
| Hallym University Kangnam Sacred Heart Hospital | OTHER |
| Korea University Anam Hospital |
Not provided
Not provided
Not provided
Not provided
Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273 COVID-19 vaccine | Biological | two doses of mRNA-1273 vaccine at 28-day intervals |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joon Young Song | Contact | +82226263052 | infection@korea.ac.kr | |
| Min Joo Choi | Contact | 82226262462 | cowgow@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Joon Young Song | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic Kwandong University | Recruiting | Incheon | South Korea |
We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
| Korean Center for Disease Control and Prevention | OTHER_GOV |
Not provided
Not provided
Not provided
blood sample
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 |
| Kangnam Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Ajou University School of Medicine Hallym University | Recruiting | Suwon | South Korea |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |