US company COVAXX has announced positive interim data from Phase I clinical trial of its Covid-19 vaccine candidate, UB-612, conducted in Taiwan.
UB-612 is a multitope peptide-based vaccine designed to stimulate both B and T-cell arms of the immune system to fight against SARS-CoV-2.
It also permits for successful cold chain management with existing infrastructure as the vaccine is stable at 2°C to 8°C.
The study analysed the safety, tolerability and immunogenicity of two doses of UB-612 at three dose levels (10, 30 and 100µg) in 60 healthy adults aged 20 to 55.
Results showed that UB-612 elicited robust antibody responses comparable to those seen in human convalescent sera.
Two doses of the vaccine induced neutralising antibodies in all trial subjects and was generally well-tolerated, with a promising safety profile.
Furthermore, the 100ug dose of the vaccine induced anti-S1-RBD and viral neutralising antibody responses compared favourably to responses observed in hospitalised patients who had recovered from Covid-19.
COVAXX chief medical officer Gray Heppner said: “These results are very promising. We are encouraged by the data and are accelerating our Phase II/III programme to deploy a safe and effective vaccine candidate to combat this pandemic.”
At present, COVAXX is conducting Phase II clinical trials of UB-612 in Taiwan with a grant from Taiwan’s Ministry of Health and Welfare. In collaboration with Aurobindo, the company is set to initiate Phase II/III trials in India.
The company along with the largest clinical diagnostic company in Brazil, Diagnosticos da America (DASA), will carry out Phase II/III clinical trials and distribute vaccines in the country.
COVAXX also entered a global logistics partnership with shipping and integrated logistics provider Maersk to create a framework for all transportation and supply chain services required for delivering the vaccine across the globe.
It has also made advance purchase commitments and agreements for UB-612 to supply doses to various countries including low-income ones.
Last September, COVAXX started dosing healthy adult participants in a Phase I clinical trial of UB-612 in Taiwan.