Codagenix, in collaboration with the Serum Institute of India, announced dosing has been initiated in an international, multi-center, randomized placebo-controlled Phase 3 clinical trial of CoviLiv. This Phase 3 efficacy evaluation is part of the World Health Organization's (WHO) Solidarity Trial Vaccines to support the development of second-generation COVID-19 vaccines with greater efficacy, greater protection against variants of concern, longer duration of protection, improved storage and/or simplified delivery with needle-free administration.
CoviLivTM is a live-attenuated, intranasal vaccine that expresses all SARS-CoV-2 proteins, not just spike, enabling induction of broad immunity to numerous viral antigens and potentially increasing efficacy against variants. The vaccine was designed using the Codagenix platform technology that re-codes the genetic material of a virus – converting the virus from disease-causing pathogen into a stable and safe, live-attenuated vaccine.
"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," said J. Robert Coleman, Ph.D., M.B.A., Co-founder and Chief Executive Officer of Codagenix. "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."
The global Phase 3 trial will evaluate the safety, efficacy, and immunogenicity of CoviLiv against circulating SARS-CoV-2 strains as compared to placebo in up to 20,000 healthy adults in countries with low-vaccination rates on the continents of Africa and possibly South America and Asia. The primary endpoint of the trial is efficacy against confirmed disease.
Early clinical data on CoviLiv confirms that the chosen dose of the live-attenuated intranasal vaccine had a 100% seroresponse rate and induced mucosal immunity capable of preventing nasal replication. Furthermore, CoviLiv has been shown to stimulate broad cellular immune responses spanning several SARS-CoV-2 – proteins, which are largely conserved across SARS-CoV-2 variants, including those found in Omicron BA.2.
In addition to the Phase 3 efficacy trial, Codagenix and the Serum Institute of India are also investigating the potential of CoviLiv as an intranasal booster in a U.K.-based Phase 1 clinical trial. This ongoing study will evaluate booster response in healthy adults previously immunized with mRNA or adenovirus-vectored COVID-19 vaccines.
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