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

COVID-19 (Healthy Volunteers) Clinical Trial

Official title: A Phase I, Placebo-controlled, Randomized, Observer-blinded, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults Aged at 19 to 55 Years

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a first-in-human, Phase I, randomized, placebo-controlled, observer-blinded study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults.

A total of 50 healthy adults between 19 and 55 years of age will be enrolled and block-randomized in a 4:1 ratio to receive 2 doses of either one NBP2001 formulation (Test group 1 or 2) or placebo saline (Placebo group).

Over the study period, participants will commonly attend 10 planned visits. Telephone calls will be made 7 days after each vaccination (Day 7+3 after Visit 2 and Visit 4). However, sentinel participants will be required to return at Day 7(+ 3 days) after 1st vaccination for rigorous safety assessment.

Study vaccination will comprise 2 intramuscular injections of saline placebo, or a 30 or 50μg dose of NBP2001 in an injection volume of approximately 0.5mL. The study vaccines will be injected preferably into the deltoid muscle of the upper arm at a 28-day interval.

Halting rules based on reactogenicity and safety outcomes are defined, and enrollment and study vaccination may be paused during the study if any halting rules are met. ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 (Healthy Volunteers)

• NCT number: NCT04760743
• Study type: Interventional
• Source: SK Bioscience Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2020
• Completion date: March 2, 2022