Intranasal COVID-19 Vaccine Shows High Seroresponse

A Phase I randomized, double-blind, placebo-controlled dose-escalation study in healthy adults, called CDX-CoV-001, has found Codagenix’s intranasal COVID-19 vaccine candidate, CoviLiv, showed the vaccine had a high seroresponse rate and induced mucosal immunity in volunteers not previously vaccinated or infected. 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 variants.

“After two doses of CoviLiv, all participants exceeded a two-fold increase in spike-specific IgG with a geometric mean fold rise of 19.5 (95% CI 3.4-113.8) on day 57. Neutralizing antibodies at this timepoint were induced 2.6-fold (CI 1.0-7.0) and 4.9-fold (CI 1.4-16.6) using MNT and PVN. On day 36 post-vaccination, IFNγ response by ELISpot after restimulation with the SNMO peptide pool increased 4.5-fold (CI 2.8-7.4) in the 2-dose cohort and 2.5-fold (CI 1.4-4.2) in the 1-dose cohort,” the investigators wrote.

CoviLiv is a live-attenuated, intranasal vaccine that expresses all SARS-CoV-2 proteins, not just the spike protein, enabling the induction of broad immunity to numerous viral antigens and potentially increasing protective efficacy against variants. The vaccine was designed using the Codagenix platform technology that recodes the genetic material of a virus, converting the virus from a disease-causing pathogen into a stable and safe, live-attenuated vaccine.

According to Johanna K. Kaufmann, PhD, executive vice president of oncology and immunology at Codagenix, the novel vaccine has a place in the market, especially internationally. She says the vaccine does not require deep refrigeration, which would make it easier to use in parts of Africa, Asia and Central America. She expects a low cost of goods for the vaccine working with the company’s partner, the Serum Institute of India. And lastly, she says the unique mechanism of action is a way the vaccine differentiates itself. “We hope that the immune response has a different quality than that of other currently available vaccines that may provide opportunities for cross strain or cross variant protection,” Dr. Kaufmann said.

However, Dr. Kaufmann says it is important to note the context of the trial, including that it was performed during 2021 through 2022 as part of a primary series vaccination. She notes the public health transition to utilizing boosters and that Codagenix has responded to that.