Novel Intranasal COVID-19 Vaccine Induces Humoral and Cellular Immunity

A clinical-stage biotechnology company, Codagenix, is presenting a late breaking abstract at IDWeek 2023 today on its intranasal COVID-19 vaccine candidate, CoviLiv. The phase 1 trial 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 2 doses of CoviLiv, all participants exceeded a 2-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.

The phase 1 trial, CDX-CoV-001, was a randomized, double-blind, placebo-controlled dose-escalation study in healthy adults, that established its safety and tolerability.

Johanna K. Kaufmann, PhD, executive vice president, Oncology and Immunology, Codagenix, says it is important to note the context of the trial including that it was performed during 2021-2022 as part of a primary series vaccination. She notes the public health transition to utilizing boosters and that Codagenix has responded to that.

“Obviously these days COVID vaccination discussions have to think about boosters,” Kaufmann said. “We are testing CoviLiv in the context of booster administration; we have completed a phase 1 clinical trial in this particular setting for which we will release data at a future point in time.”

Kaufmann says 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 their 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,” Kaufmann said.

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 re-codes the genetic material of a virus, converting the virus from a disease-causing pathogen into a stable and safe, live-attenuated vaccine.

The vaccine is being jointly developed by Codagenix and the Serum Institute of India Pvt. Ltd. (SIIPL). SIIPL, the world's largest vaccine manufacturer who is manufacturing the vaccine for this clinical study.

Earlier this month, the company announced that the Biomedical Advanced Research and Development Authority (BARDA) had entered into a contract with Codagenix to support the costs of a phase 2b clinical study for the COVID-19 vaccine candidate.

The company said this is in addition to its ongoing phase 3 efficacy study of CoviLiv being conducted as part of the World Health Organization's Solidarity Trial Vaccines.

Contagion spoke to Kaufmann who offered further insights on the company’s plans for the vaccine as well as the study’s findings.

Click here for more coverage of IDWeek 2023.

REFERENCE

Kaufmann J, Wyllie K, et al. A Novel Intranasal Live-Attenuated COVID-19 Vaccine Candidate, Induces Robust Humoral and Cellular Immunity in First-In-Human Clinical Trial CDX-CoV-001. Presented at: IDWeek 2023. October 11-14, 2023; Boston, MA. Abstract 1938.