Australian company Technovalia and its partners Chulalongkorn University and BioNet have announced ethics approval for a phase 2 trial of the ChulaCov19 BNA159 mRNA vaccine as a booster dose in adults.
The partners said the approval has been granted following satisfactory results of clinical safety and immunogenicity data of previous trials of the vaccine candidate.
Technovalia CEO Laurent Dapremont said, “We are pleased to have received ethics approval for testing the ChulaCov19 mRNA BNA159 vaccine. We have been leading the development of genetically designed innovative vaccines in Australia, starting with clinical trials evaluating a recombinant pertussis vaccine, two DNA COVID vaccines and now a mRNA COVID vaccine.”
The phase 2 trial will assess the safety and immunogenicity of one single booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers having previously received vaccination with an approved COVID-19 vaccine.
The trial includes several sites in Australia and will commence in November.
The ChulaCov19 mRNA vaccine was developed by Professor Kiat Ruxrungtham and his team at Chulalongkorn University Vaccine Research Center (ChulaVRC) in Thailand, in collaboration with Professor Drew Weissman of the University of Pennsylvania.
The first ChulaCov19 vaccine lot was manufactured in the US and was evaluated in a phase 1 safety trial in Thailand.
The new multi-centre trial in Australia will evaluate the boosting immunity induced by one dose of ChulaCov19 BNA159 vaccine, produced in Thailand, in adults aged 18 – 64 years.
BioNet CEO Dr Pham Hong Thai added, “We are very pleased to collaborate with Chulalongkorn University to produce mRNA vaccines against SARS-CoV-2 and to continue our development partnership with Technovalia. We have been collaborating on several vaccines of which three are in clinical trial stage in Australia. This is a key milestone for all our colleagues who worked relentlessly towards the success of this mRNA vaccine project.”