Codagenix and the Serum Institute of India have begun a first-in-human clinical trial of their single-dose intranasal COVID-19 vaccine. The partners are assessing the live attenuated candidate, COVI-VAC, in a 48-subject phase 1 clinical trial in the U.K.
Dosing in the phase 1 at a site run by hVIVO is scheduled to start early next year, putting Codagenix and the Serum Institute well behind the leaders in the COVID-19 vaccine race. However, an effective single-dose intranasal vaccine could come from behind to carve out a space in the market if booster shots are needed to sustain protection against the virus and keep the outbreak under control.
COVI-VAC is stable outside of the ultralow temperature freezers essential to the storage of Pfizer and BioNTech’s vaccine, making it easier to ship globally. Equally, providing protection after one dose would simplify logistics and eliminate the risk people will fail to return to get their second shot.
“We believe that there are still clear challenges in actually rolling out these vaccines and supplying the global community,” Codagenix CEO J. Robert Coleman said in a statement. “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, working with the Serum Institute and hVIVO, is starting to put the vaccine to the test. The double-blind, placebo-controlled, dose-escalation phase 1 will assess the safety and tolerability of a single dose of COVI-VAC delivered via nose drops. The trial will also assess immunogenicity.
The vaccine is based on Codagenix's Synthetic Attenuated Virus Engineering platform, which recodes the genes of viruses into vaccines using synthetic biology. Codagenix partnered with the Serum Institute, which makes more vaccine doses a year than any other company, to access the manufacturing scale needed to support its plans to establish COVI-VAC as a cornerstone of mass vaccination programs.
COVI-VAC is one of a clutch of second-generation COVID-19 vaccine candidates designed to protect people against COVID-19 without using needles. Like Codagenix and the Serum Institute, Altimmune has a single-dose intranasal candidate in development. Altimmune is set to publish phase 1 data early next year. Vaxart is closing in on the delivery of clinical data on its oral candidate, and ImmunityBio is preparing to take its oral prospect into the clinic.