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On October 13, 2023, we reported on findings presented at IDWeek 2023, held October 11-15 in Boston, MA.
A randomized, placebo-controlled phase 1 CDX-CoV-001 clinical trial of CoviLivTM, a novel vaccine candidate that is derived from SARS-CoV-2/Wuhan that is engineered to genetically convert the virus from disease-causing pathogen to stable, safe live-attenuated vaccine. CDX-CoV-001 was a dose escalation study of CoviLiv used a primary vaccination series in healthy adults to establish the vaccine's safety and tolerability.
Data presented at the meeting highlighted the immune response to CoviLiv among participants in the study cohort that received the highest dose of 5x106 pfu (n=6/group).
Investigators characterized humoral immune response on days 1, 29, and 57 and analyzed T-cell functionality on days 1 and 36.
On post-vaccination study day 57, after 2 doses of the intranasal vaccine, researchers reported a greater than 2-fold increase in spike-specific IgG among all participants, with a geometric mean fold rise of 19.5.
Neutralizing antibodies at day 57 were induced 2.6-fold based on microneutralization assay and by 4.9-fold using pseudovirus neutralization assay.
On post-vaccination day 36, after restimulation with a variety of SARS-CoV-2 peptides to mimic virus strains and variants, T-cell response increased by 2.5-fold in the study cohort receiving 1 dose and by nearly double that, 4.5-fold, in the 2-dose cohort.
“The study findings provide a glimpse into what could be the next generation of COVID-19 vaccines that provide differentiated protection to more people. Vaccine administration by nose and easier storage can increase access to vaccinations for underserved areas across the world."