January 11, 2021 -- The first patient has been dosed in a phase I clinical trial being conducted by Codagenix and the Serum Institute of India of COVI-VAC, a single-dose, intranasal vaccine against the SARS-CoV-2 virus.
Codagenix and the Serum Institute of India announced the start of the phase I trial in December following regulatory approval from the U.K. Medicines and Healthcare Products Regulatory Agency. It is operating as a randomized, double-blinded, placebo-controlled dose-escalation study among 48 volunteers.
Open Orphan subsidiary hVIVO is conducting the study, which will evaluate COVI-VAC's safety and tolerability as well as its ability to provoke an immune response. The formulation has the advantage of only requiring a single dose and not needing a needle, syringe, or ultra-low-temperature storage.
Codagenix intends to report initial data by the middle of this year, with plans to begin advanced clinical testing soon after.