COVID-19 Vaccine Reactogenicity and Immunogenicity

NCT05258708 | Unknown FDA Drug

• 1 other identifier: 2021GR0274
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

COVID-19; Vaccine Immune Response; Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• anti-SARS-CoV-2 antibody

  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

  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

  Seven days after each dose of vaccine

• Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer

  At 3 months and 6 months after dose 1

Interventions

mRNA-1273 COVID-19 vaccine BIOLOGICAL

two doses of mRNA-1273 vaccine at 28-day intervals

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• who were willing to receive the mRNA-1273 vaccine

You may not qualify if:

• previously diagnosed with laboratory-confirmed COVID-19
• history of autoimmune disease
• immunocompromised, pregnant, or breastfeeding

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Catholic Kwandong University: collaborator
• Ajou University School of Medicine: collaborator
• Hallym University Kangnam Sacred Heart Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (5)

Catholic Kwandong University

Incheon, South Korea

RECRUITING

Kangnam Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Ajou University School of Medicine Hallym University

Suwon, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joon Young Song

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon Young Song

CONTACT

+82226263052; infection@korea.ac.kr

Min Joo Choi

CONTACT

82226262462; cowgow@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: February 28, 2022
• Study Start: June 24, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

KR (5)