The Phase I segment of the trial is targeting 50 participants to ascertain the optimal booster dose between 100μg and 250μg. Credit: BaLL LunLa / Shutterstock.

Health Canada has granted approval to Entos Pharmaceuticals to commence a Phase I/II clinical trial of its investigational Covid-19 vaccine booster, Covigenix VAX-002.

Developed using Entos’ Fusogenix PLV delivery platform, Covigenix VAX-002 is a plasmid DNA vaccine designed to express crucial SARS-CoV-2 antigens. It focuses on the Omicron strains currently in circulation.

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Aegis Life holds the worldwide rights for the vaccine outside of the country and is collaborating with Entos on the vaccine’s clinical development.

The Phase I segment of the trial is targeting 50 participants to ascertain the optimal booster dose between 100μg and 250μg.

Following this, the Phase II part of the study will recruit 250 participants to assess the safety and immunogenicity response of the dose determined in Phase I.

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The outcomes of the trial will inform the intramuscular dosing strategy for future Covigenix formulations and support global development strategies.

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The booster vaccine is being manufactured at Entos’ Good Manufacturing Practices (GMP) plant located in Carlsbad, California, US.

This site was established to facilitate the clinical development of Entos’ genetic medicine programmes, including Covigenix VAX-002, and to support partnered programmes and projects targeting rare diseases, ophthalmic conditions, oncology, and infectious diseases.

Entos chief medical officer Steve Chen said: “Elderly and immunocompromised patients are still in need of a Covid-19 vaccine that can provide durable and robust protection. Developing countries are also still in need of a fridge-stable vaccine that can be deployed rapidly.

“Covigenix VAX-002 has the potential to be the first DNA fridge-stable vaccine offering longer-lasting protection than any other vaccine currently on the market.”