NCT05258708

COVID-19 Vaccine Reactogenicity and Immunogenicity

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 179 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Vaccine Immune Response
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273 COVID-19 vaccine	two doses of mRNA-1273 vaccine at 28-day intervals

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2022-02-28
• Last updated: 2022-02-28

Locations

5 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study