NCT04742842

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

A Phase I, Double-blind, Dose-ranging, Randomised, Placebo-controlled Trial to Study the Safety and Immunogenicity of a DNA-based Vaccine Against COVID-19 (COVIGEN) in Healthy Participants Aged 18 to 75 Years Old

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A Vaccine Naïve participants: The study comprises three dose groups (0.8 mg COVIGEN, administered ID, 2 mg COVIGEN, administered IM and 4 mg COVIGEN, administered IM) with 50 participants in each group. Each group of 50 participants comprises two sub-groups: 25 young adults and 25 older adults. Within each group and within each sub-group, participants will be randomised 4:1 to receive COVIGEN or placebo in a double-blind fashion. Participants will receive 2 study vaccinations, 28 days apart (Day 1 and Day 29). Each dose will be divided into 2 injections, with each injection being administered using a needle free injection system into the upper arm (left and right) at each visit. The study will utilise a sequential dose-escalating design with a 48-hour observation period required for sentinel participants prior to the decision to dose escalate. Enrolment of the remainder of each age cohort will commence at least 48 hours after the last of the sentinel participants has received a vaccine. A Safety Review Committee (SRC) will supervise enrolment and monitoring of participant safety throughout the trial Part B: Vaccine booster participants: The study comprises a single dose group (1.0mg COVIGEN, administered ID) to 50 participants in total, comprising 25 participants who have received a primary course of 2 doses of Pfizer BioNTech vaccine and 25 participants who have received a primary course of 2 doses of Astra Zeneca vaccine. The dose will be divided into 2 injections, with each injection being administered using a needle free injection system into the upper arm (left and right) at each visit. Participants 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

Type	Name	Description
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

Timeline

• Start date: 2021-06-21
• Primary completion: 2022-07-30
• Completion: 2023-07-30
• First posted: 2021-02-08
• Last updated: 2023-10-30

Locations

3 sites across 1 country: Australia