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Clinical Trials List

Protocol NumberCT-COV-11
NCT Number(ClinicalTrials.gov Identfier)NCT04487210

2020-09-01 - 2022-01-31

Phase I

Terminated1

ICD-10B33.8

Other specified viral diseases

ICD-10B34.1

Enterovirus infection, unspecified

ICD-10B34.2

Coronavirus infection, unspecified

ICD-10B34.3

Parvovirus infection, unspecified

ICD-10B34.4

Papovavirus infection, unspecified

ICD-10B34.8

Other viral infections of unspecified site

ICD-10B97.19

Other enterovirus as the cause of diseases classified elsewhere

ICD-10B97.21

SARS-associated coronavirus as the cause of diseases classified elsewhere

ICD-10B97.29

Other coronavirus as the cause of diseases classified elsewhere

ICD-10B97.5

Reovirus as the cause of diseases classified elsewhere

ICD-10B97.6

Parvovirus as the cause of diseases classified elsewhere

ICD-10B97.81

Human metapneumovirus as the cause of diseases classified elsewhere

ICD-10B97.89

Other viral agents as the cause of diseases classified elsewhere

ICD-9079.89

Other specified viral infection in conditions classified elsewhere and of unspecified site

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

  • Trial Applicant

    Medigen Vaccine Biologics corp.

  • Sponsor

    Medigen Vaccine Biologics Corp.

  • Trial scale

    Taiwan Single Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Szu-Min Hsieh Division of Infectious Disease

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

COVID-19

Objectives

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

Test Drug

MVC-COV1901 vaccine (暫定)

Active Ingredient

SARS-CoV-2 S-2P棘蛋白

Dosage Form

injection(Prefilled Syringe )

Dosage

Ag 5, 15 or 25mcg+CpG/Alum

Endpoints

Safety of MVC-COV1901 [ Time Frame: Day 1 to 28 days after second vaccination ]
Incidence of solicited adverse events (AEs) after vaccination, Incidence of unsolicited AEs and other AEs after vaccination, Incidence of laboratory abnormality after vaccination, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) after vaccination

Inclution Criteria

Inclusion Criteria:
Male or female healthy volunteer ≥20 and <50 years of age

Exclusion Criteria

Exclusion Criteria:
Receiving any investigational intervention either currently or within 30 days of first dose;

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    45 participants