The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers

Summary

In this trial, we are evaluating the safety and tolerability of a new investigational DNA vaccine to protect against SARS CoV-2 virus, called COVIGEN, that is developed by a company called BioNet-Asia.

A device will be used to inject the vaccine that does not require the use of a needle (needle-free injection made by a company called Pharmajet). For delivery into the skin (intradermally) a device called "Tropis" will be used, and for delivery into the muscle (intramuscularly) a device called "Stratis" will be used.

This is a 2 part study

In Part A vaccine naive participants will be given 2 vaccinations, either two active vaccines or two placebo vaccines on Day 1 and Day 29. COVIGEN C19 vaccine will be used in Part A

In Part B participants who have previously received a 2-dose primary COVID vaccine schedule will be given a booster dose of active vaccine. COVIGEN C20 vaccine will be used in Part B.

Participants in part A and B will be followed up using a combination of on-site and telephone visits for assessment of safety and immunogenicity for 12 months from 1st vaccination.

Conditions

• SARS-CoV2 COVID-19

Interventions

BIOLOGICAL

COVIGEN C19 0.8 mg ID or Placebo ID

2 doses of COVIGEN C19 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.

BIOLOGICAL

COVIGEN C19 2.0 mg IM or Placebo IM

2 doses of COVIGEN C19 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.

BIOLOGICAL

COVIGEN C19 4.0 mg IM or Placebo IM

2 doses of COVIGEN C19 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29.

BIOLOGICAL

COVIGEN C20 1.0mg vaccine ID

COVIGEN C20 1.0mg ID vaccine will be given at Day 1

Sponsors & Collaborators

• Bionet Co., Ltd

  collaborator INDUSTRY

• Technovalia

  collaborator INDUSTRY

• Telethon Kids Institute

  collaborator OTHER

• Institute for Clinical Pathology and Medical Research

  collaborator UNKNOWN

• University of Sydney

  lead OTHER

Principal Investigators

• Nicholas WOOD, MB BS FRACP PhD. · University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-21

Primary Completion

2022-07-30

Completion

2023-07-30

Countries

• Australia

Study Locations