UB-612 was generally well-tolerated with a promising safety profile. Credit: Diana Polekhina on Unsplash.

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.

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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.