NCT04487210

A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19

A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.

Detailed description

This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms for subjects at the age of ≥20 and \<50 years. The vaccination schedule for primary regimen consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular (IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day 209, 180 days after completion of the primary regimen.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901	MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.

Timeline

• Start date: 2020-10-07
• Primary completion: 2021-06-01
• Completion: 2021-12-06
• First posted: 2020-07-27
• Last updated: 2022-01-31

Locations

1 site across 1 country: Taiwan