COVIGEN, a New COVID-19 Vaccine Candidate in Australia

March 22, 2021 Supachai

University of Sydney receives approval to start COVALIA, a Phase 1 Clinical Trial of COVIGEN

First needle-free DNA-based COVID-19 candidate vaccine to be tested in Australia in a Phase 1 trial in healthy subjects aged 18 to 75 years old

technovaliaBioNet needle-free COVID-19 gene-based vaccine (COVIGEN) has been received ethics approval to start a phase 1 clinical trial in Australia (COVALIA), which has shown to be safe and immunogenic in pre-clinical trials.

This phase 1/1b, multi-centre, observer-blinded, dose-ranging, randomized, placebo-controlled trial will assess the safety, reactogenicity and immunogenicity of different doses of COVIGEN given to healthy subjects aged 18 to 75 years old. The key goal is to examine the safety of 2 doses of COVIGEN, given 1 month apart.

The COVALIA trial is a partnership with Technovalia, and Australia’s most experienced vaccine trial sites including the University of Sydney, the Telethon Kids Institute in Perth, the University of Adelaide, the Vax4COVID alliance. This study has been awarded from the Australian Medical Research Future Fund (MRFF) Coronavirus Research Response. The vaccine will be tested in three states across Australia (NSW, SA, and WA).

About the COVALIA trial

The phase 1, multi-centre, double-blind, dose-ranging, randomised, placebo-controlled trial will assess the safety, reactogenicity and immunogenicity of different doses of COVIGEN given to healthy subjects aged 18 to 75 years old. As a phase 1 trial, the key goal is to examine the safety of two doses of COVIGEN, given one month apart. If the trial is successful, then a phase 2 trial will be undertaken in a larger number of participants.

The Lead Investigator, A/Prof Nicholas Wood, at the University of Sydney Children’s Hospital Westmead Clinical School says: “We are excited to start enrolment along with our colleagues in Perth and Adelaide, and to undertake the first needle-free COVID vaccine trial in Australia. The start of the COVALIA study is a significant milestone for all involved in this one-of-a-kind partnership between Australian institutions, the industry and the Australian government via the The Medical Research Future Fund (MRFF).”

Mr. Laurent Dapremont, Chief Executive Officer of Technovalia said: “We are very pleased that the COVALIA trial received the green light to start recruiting in the coming weeks. This is the result of a global partnership which started in 2020 with the COVIGEN project. We believe nucleic acid vaccines will play an important role to combat the pandemic, especially with the emergence of new SARS-CoV-2 variants, and we are looking forward to working with all our partners to bring and produce in Australia this COVID-19 DNA-based vaccine.”

[source : https://technovalia.com/media-releases/university-of-sydney-receives-approval-to-start-covalia-a-phase-1-clinical-trial-of-covigen]

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