Technovalia has announced the interim safety results of the ongoing phase 1 clinical trial evaluating COVIGEN, a DNA Covid-19 vaccine candidate, in healthy participants using the PharmaJet Needle-free Devices.
The company said interim safety data showed Covigen is well tolerated and no safety concerns were observed. Full safety data are expected by February 2022.
The phase 1 trial involved 27 participants to assess the safety and immunogenicity of two COVIGEN doses given to healthy volunteers who had not yet had a COVID-19 vaccine.
The trial is ongoing and now recruiting in three states across Australia (NSW, SA, and WA) for the evaluation of COVIGEN as a booster on volunteers having received two doses of the available vaccines in Australia.
Lead principal investigator, Associate Professor Nicholas Wood of The University of Sydney Children’s Hospital Westmead Clinical School said, “Analysis of safety data from the first sentinel groups of volunteers enrolled in the COVALIA study show no safety concerns, and that the tolerability profile is comparable or lesser to that of mRNA COVID-19 vaccines. Amid the pandemic, it is now also important to assess the safety and immunogenicity of one dose of Covigen as a booster in already fully vaccinated volunteers.”
Technovalia CEO Laurent Dapremont said, “We are pleased with these positive interim safety results from the ongoing COVALIA study which reinforce the existing pre-clinical data available. COVIGEN is the first plasmid-DNA vaccine to be tested in Australia and it is encouraging to observe no safety concern in the participants. We believe both mRNA and DNA vaccines will play an important role to combat the spread of Covid.”