Clinical trial NCT05258708: COVID-19 Vaccine Reactogenicity and Immunogenicity
Official title: Predictive Value of Reactogenicity for Anti-SARS-CoV-2 Antibody Response in mRNA-1273 Recipients: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Vaccine Immune Response
Vaccine Adverse Reaction
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Catholic Kwandong University
name: Ajou University School of Medicine
name: Hallym University Kangnam Sacred Heart Hospital
name: Korea University Anam Hospital
name: Korean Center for Disease Control and Prevention
First posted: 2022-02-28
Enrollment: 179
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The correlation between humoral immune response and reactogenicity after vaccination
timeFrame: 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 outcomes:
measure: anti-SARS-CoV-2 antibody
timeFrame: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
measure: neutralizing antibody titer
timeFrame: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
measure: reactogenicity after vaccination
timeFrame: Seven days after each dose of vaccine
measure: Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer
timeFrame: At 3 months and 6 months after dose 1
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine Hallym University
Study officials:
affiliation: Korea University Guro Hospital
name: Joon Young Song
role: PRINCIPAL_INVESTIGATOR
References: