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Safety and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults (COVID-19)

NCT04760743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-18

No results posted yet for this study

Summary

This study is to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults.

Conditions

  • COVID-19 (Healthy Volunteers)

Interventions

BIOLOGICAL

NBP2001 adjuvanted with alum (RBD 30μg/dose)

Participants will receive intramuscular (IM) injections of NBP2001(RBD 30μg/dose) on Days 0 and 28.

BIOLOGICAL

NBP2001 adjuvanted with alum (RBD 50μg/dose)

Participants will receive intramuscular (IM) injections of NBP2001(RBD 50μg/dose) on Days 0 and 28.

OTHER

Normal Saline

Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Myoung-Don Oh · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2021-04-02
Completion
2022-03-02

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760743 on ClinicalTrials.gov