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COVID-19 Vaccine Reactogenicity and Immunogenicity

NCT ID: NCT05258708

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2022-05-30

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.

Conditions

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COVID-19 Vaccine Immune Response Vaccine Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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mRNA-1273 COVID-19 vaccine

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

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic Kwandong University

OTHER

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role collaborator

Korean Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joon Young Song

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon Young Song

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Catholic Kwandong University

Incheon, , South Korea

Site Status RECRUITING

Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status 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

Site Status RECRUITING

Ajou University School of Medicine Hallym University

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon Young Song

Role: CONTACT

Phone: +82226263052

Email: [email protected]

Min Joo Choi

Role: CONTACT

Phone: 82226262462

Email: [email protected]

Facility Contacts

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Min Joo Choi

Role: primary

Yu Bin Seo

Role: primary

Young Kyung Yoon

Role: primary

Joon Young Song

Role: primary

Seung Hoe Song

Role: backup

Jung Yeon Heo

Role: primary

Other Identifiers

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2021GR0274

Identifier Type: -

Identifier Source: org_study_id