COVID-19 Vaccine Reactogenicity and Immunogenicity

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

Detailed Description
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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.

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

Conditions
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COVID-19, Vaccine Immune Response, Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: mRNA-1273 COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: mRNA-1273 COVID-19 vaccine|two doses of mRNA-1273 vaccine at 28-day intervals|

What is the study measuring?
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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 |