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US based Codagenix Inc and the Serum Institute of India Pvt Ltd (SII) have announced that the first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19.
Designed as a randomised, double-blinded, placebo-controlled dose-escalation study, the Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability COVI-VAC. In addition, the study will evaluate the vaccine's ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. Codagenix expects to report initial data from the study by mid-2021. Pending results of the Phase 1 trial, Codagenix and SIIPL expect to begin advanced clinical testing in mid-2021. The trial is being conducted by hVIVO in London, UK, a subsidiary of Open Orphan plc.
J Robert Coleman, CEO, Codagenix said, "Importantly, as a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus. This could prove critical as new variants of SARS-CoV-2 have begun to emerge.”
Charlie Petty, Principal, Adjuvant Capital and Codagenix board member said, "We are optimistic that COVI-VAC can play an important role in achieving equitable access to protection from SARS-CoV-2, and the Serum Institute of India is the ideal partner to achieve our large-scale distribution amibitions.”
COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which uses synthetic biology to re-code the genes of viruses into safe and stable vaccines.
