December 14, 2020 -- Codagenix and the Serum Institute of India have begun a phase I clinical trial of COVI-VAC in London after receiving regulatory approval from the Medicines and Healthcare Products Regulatory Agency in the U.K.
COVI-VAC is an intranasal, live-attenuated vaccine against SARS-CoV-2. Unlike some other vaccine types, COVI-VAC requires only a single dose and does not require a needle, syringe, or ultralow storage.
The single dose, intranasal administration may help address logistical challenges to immunization, according to the companies. In addition, it can be manufactured at a large scale and is easy to administer for mass vaccination campaigns.
Open Orphan subsidiary Hvivo will conduct the phase I trial in London, and patient recruitment for the randomized, double-blind study has already begun. The first participants will receive a dose in early January 2021.
The trial will be a placebo-controlled and dose-escalation study designed to evaluate the safety and tolerability of a single dose of COVI-VAC. It will also evaluate whether COVI-VAC may produce a more robust and longer lasting immune response to the novel coronavirus than other vaccine types.
Codagenix used its synthetic attenuated virus engineering (SAVE) platform to develop the vaccine, which was shown to be safe and effective in preclinical animal studies.
Codagenix and the Serum Institute of India expect to begin advanced clinical testing in mid-2021.