The University of Sydney, Technovalia, and Vax4COVID recently shared their ethics committee has authorized the greenlight of a Phase 1 clinical trial of the COVIGEN COVID-19 vaccine candidate in Australia. Led by Principal Investigator Professor Nicholas Wood at the University of Sydney Children’s Hospital Westmead Clinical School, the study received human research ethics approval for the Phase 1 study in healthy participants ranging in age from 18 to 75. Participant screening commenced this month while this ethics approval process represented the first independent review of COVIGEN preclinical and efficacy data. This study evaluates a needle-free DNA-based COVID-19 vaccine candidate to be tested in Australia. This research was made possible by an impressive collaboration involving University of Sydney, a life science commercialization venture called Technovalia, an alliance of trial site networks known as Vax4COVID, and a Thailand-based vaccine manufacturer that launched a former executive of Chiron (acquired by Novartis) heading vaccine development in Southeast Asia. The needle-free technology is developed by Colorado-based Pharmajet.
This Phase 1 trial is the result of intensive collaboration between various Australian groups (academia, government, life sciences sector) as well as a Thai vaccine manufacturer. Leading the commercialization is Melbourne-based Technovalia, a privately-owned Australian biotech venture.
TrialSite breaks down the updates here.
What is this vaccine candidate known as COVIGEN?
COVIGEN is a needle-free, DNA-based vaccine sponsored by BioNet Asia and University of Sydney, Australia.
What are study details?
The vaccine will be tested in three states across Australia (NSW, SA, and WA) through Vax4COVID, an alliance of Australian vaccine clinical trial centers. The phase 1 trial involves 150 participants to assess the safety and immunogenicity in healthy volunteers. Screening and enrolments of participants start this month.
Known as the “COVALIA” study (NCT04742842) sponsored by University of Sydney, the trial team evaluates the safety and tolerability of a new investigational DNA vaccine to protect against COVID-19 called COVIGEN developed by BioNet Asia.
The 150 Australian study involves a device used to inject the vaccines that excludes use of a needle (it’s a needle-free injection made by a company called Pharmajet). This delivery model is used to deliver the investigational vaccine into the skin (intradermally) via device called “Tropis” and for delivery into the muscle (intramuscularly) a device called “Stratis” is employed.
Each participant is given two (2) vaccinations, either two active vaccines or two placebo vaccines on Day 1 and Day 29. The study participants will be followed up on via a combination of onsite and telephone visits for assessment of safety and immunogenicity for 12 months after the first vaccination.
What is Vax4COVID?
Vax4COVID is an Australian alliance of experienced trial sites formed to facilitate the conduct of COVID-19 vaccine testing. The alliance is led by the Doherty Institute of Infection and Immunity.
What are the Sites Involved?
Vax4COVID trial sites include the following:
· Doherty Institute: Vaccine and Immunisation Research Group
· Melbourne Children’s Trial Centre (MCTC), Murdoch Children’s Research Institute, Royal Children’s Hospital
· VIC State Clinical Trials Network: Department of Health and Human Services Victoria Coordinating Office for Clinical Trial Research
· The Westmead Institute for Medical Research
· University of Queensland: Faculty Of Medicine, University Of Queensland
· Government of South Australia: Women’s and Children’s Health Network
· South Australian State Clinical Trials Network: SA Department for Health and Wellbeing Statewide Research Coordinator, Office for Research
· Western Australia State Clinical Trials Network:WA Department of Health Research Development Unit (Research Governance)
Who is BioNet Asia?
BioNet-Asia is a Biotech company with a manufacturing base in Asia and with clinical and business operations in Europe, Asia and Australia. Headquartered in Thailand, the company was founded in 2001 to produce vaccine products and maintains a state-of-the-art vaccine plant in Thailand. BioNet is also building a unique expertise in genetic engineering, protein conjugation, cell-culture and vaccine formulation. The company has developed a broad pipeline with ten products in R&D and clinical stages, including vaccines and recombinant proteins such as CRM197 protein carrier, dengue and hepatitis B vaccines. The company has transferred the technology to produce Hib meningitis vaccine which is now commercialized as a pentavalent vaccine in Asia. BioNet produces recombinant acellular pertussis vaccines using a proprietary technology. Their vaccines are manufactured in accordance to Good Manufacturing Practices (GMP) PIC/S standards, and tested at each manufacturing step as per pharmacopeia requirements using established validated assays in our own quality control and testing facilities. More than 150 highly-skilled employees develop the vaccines of tomorrow, from conception to distribution throughout each development stage: research, non-clinical studies, clinical trials, manufacturing and post-marketing surveillance to ensure the safety, immunogenicity and effectiveness of our vaccines.
CEO Hong Pham helped launch the company. He spent several years working for the American biotech company Chiron.
Professor Nicholas Wood, University of Sydney Children’s Hospital Westmead Clinical School