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