Codagenix has announced the initiation of a Phase 3 trial of its CoviLiv live-attenuated intranasal vaccine against COVID-19. The trial, which is being conducted in partnership with the Serum Institute of India, is part of the World Health Organization’s Solidarity Trial Vaccines trial. The Phase 3 study is expected to enroll up to 20,000 healthy adults in countries with low vaccination rates and will evaluate the ability of the vaccine to prevent disease caused by SARS-CoV-2 variants currently in circulation.
In September 2021, Codagenix announced that it intended to advance CoviLiv (formerly CoviVac) into Phase 2/3 trials based on positive results from a Phase 1 trial that had been initiated in December 2020. Earlier this year, the company initiated another Phase 1 trial in the UK that is designed to evaluate CoviLiv as a booster, and the company says that trial is ongoing.
Codagenix CEO J. Robert Coleman said, “In the face of a continually evolving COVID-19 landscape, it is imperative that we bring to market vaccines that induce broad immunity, block viral shedding via mucosal immunity, and offer protection against current and future variants of SARS-CoV-2 to countries around the world. Data from ongoing clinical evaluations indicate that CoviLiv shows promise for meeting these important criteria, and we are thrilled WHO chose CoviLiv for this pivotal Phase 3 clinical evaluation.”
Read the Codagenix press release.