COVAXX has started dosing healthy adult participants in a Phase I clinical trial of its Covid-19 vaccine candidate, UB-612, in Taiwan.
The dose-escalation study received funds worth approximately $15m from the Ministry of Health and Welfare in Taiwan.
UB-612 is a multitope peptide-based vaccine candidate that is meant to activate the B and T-cell arms of the immune system.
It is developed via genetic fusion of the Spike protein S1 subunit receptor-binding domain (RBD) to a single chain Fc domain of human IgG1 (S1-RBD-sFc).
The open-label Phase I trial will test the safety, tolerability and immunogenicity of the vaccine candidate. It is recruiting 60 healthy adults aged 20-55 across three arms, which will have 20 participants each.
Each participant will be given ascending dose levels of UB-612 in two intramuscular injections administered 28 days apart.
Immunological tests will be conducted to assess the candidate’s protective activity. The Laboratory of Molecular Virology and Viral Immunology at Academia Sinica in Taiwan will carry out the neutralisation titre analysis.
COVAXX co-CEO Mei Mei Hu said: “Administering the initial dose of our vaccine candidate to the first participants not only marks the start of this Phase I clinical trial but also represents a significant step forward in the global fight against Covid-19.”
This trial expands COVAXX’s global partnerships following deals with diagnostic medicine company Dasa and The University of Nebraska Medical Center for large scale human efficacy studies in Brazil and the US, respectively.
COVAXX chief scientific officer Farshad Guirakhoo said: “Producing a safe and effective Covid-19 vaccine within the next 12 to 18 months is not only a challenge but it also requires new levels of collaborations across healthcare industries and governments worldwide.”
The results of the Phase I trial will be analysed to determine an appropriate dose and advance the vaccine candidate to a Phase II/III trial.