Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix’s CodaVax-RSV vaccine, which is also in Phase 1 development, COVI-VAC is based on Codagenix’s SAVE codon deoptimization platform.
The Phase I trial, which will evaluate low, medium, and high doses of the vaccine, is expected to begin dosing in the first week of 2021. The study is expected to enroll 48 healthy adults aged 18 to 30 who will get either two doses of vaccine or placebo 28 days apart or a single dose of vaccine or placebo. Delivery of the vaccine will be via nasal drops in each nostril.
SIIPL Executive Director Rajeev Dhere said, “We at SIIPL are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SIIPL. The product is promising with many unique features and will make our fight against the virus stronger, and therefore, this news is surely welcoming.”
Codagenix CEO J. Robert Coleman commented, “While other vaccine candidates have received approval, and others may soon follow, we believe that there are still clear challenges in actually rolling out these vaccines and supplying the global community. The potential of COVI-VAC to meet the global demand as a single-dose, needle-free vaccine that needs only a standard freezer or fridge cannot be overstated.”
Codagenix Chief Scientific Officer Steffen Mueller said, “COVI-VAC is ideally suited for mass production using technologies already in place at global manufacturing facilities, including those of our partner, the Serum Institute of India, the largest vaccine manufacturer in the world by doses sold. Our ability to get this vaccine into a clinical trial six months after recovery of the vaccine strain is further testament to the speed and agility of the Codagenix SAVE attenuation platform.”
Read the Codagenix press release.
