Australian biotech company Technovalia has announced that the first volunteers have been enrolled and dosed in the COVALIA trial, a phase 1 study of its COVID-19 vaccine candidate, COVIGEN, in healthy participants using the PharmaJet needle-free devices.
The company said the vaccine will be tested in three states across Australia (NSW, SA, and WA) through Vax4COVID, an alliance of Australian vaccine clinical trial centres, formed to facilitate the conduct of clinical trials of SARS-CoV-2 vaccine candidates in Australia.
The phase 1 trial will involve 150 participants to assess the safety and immunogenicity in healthy volunteers. Participants are being recruited by Scientia Clinical Research (Sydney), the Telethon Kids Institute (Perth) and the Women’s and Children’s Hospital (Adelaide).
The company said preclinical studies confirmed the safety and immunogenicity of COVIGEN. If successful, a phase 2 trial will include a larger number of participants.
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. The key goal is to examine the safety of 2 doses of COVIGEN, given one month apart.
Lead principal investigator Associate Professor Nicholas Wood of The University of Sydney Children’s Hospital Westmead Clinical School said, “We are very excited to start enrolment along with our colleagues in Perth and Adelaide, and to undertake the first needle-free COVID vaccine trial in Australia.”
Technovalia CEO Laurent Dapremont said, “We are very pleased to report that the first volunteers have been enrolled and dosed in this important study. COVIGEN is the first plasmid-DNA vaccine to be tested in Australia. We believe nucleic acid vaccines will play an important role to combat the pandemic, especially with the emergence of new variants and the focus on country self-reliance for the manufacturing of essential medicines.”
According to Dr Pham Hong Thai, the CEO of BioNet, “The COVALIA study is the result of a strong collaborative effort with our partners in Australia. The COVIGEN vaccine has been developed with a technology which can be easily transferable for local production as it only requires Biosafety Level (BSL)-1 manufacturing capabilities. The technology is also very suitable for the rapid development of new variant vaccines.”
Chris Cappello, the president and CEO of PharmaJet, added, “We are pleased to be collaborating with Technovalia, BioNet and their partners as they move into human clinical trials. Our Needle-free Systems provide the platform to get vaccines directly into cells to help maximize target gene expression in the body. Our findings from multiple clinical studies with other DNA vaccines have resulted in improved effectiveness from using our devices.”