First-in-Human Trial of COVI-VAC for COVID-19

Coagenix, New York, USA, and Serum Institute, Pune, India have announced the phase of intranasal live attenuated vaccine for COVID-19. COVI-VACC is a single-dose intranasal, live attenuated vaccine against SARS-CoV-2. It was shown to be safe and efficacious in preclinical animal studies. COVI-VAC was developed with Codagenix’s Synthetic Attenuated Virus Engineering (SAVE) platform that uses synthetic biology to re-code the genes of viruses into safe and stable vaccines. The randomized, double-blind, placebo-controlled, dose-escalation trial involves 48 volunteers to be enrolled at three doses.

The trial will evaluate the safety and tolerability of a single dose of COVI-VAC administered by nose drops. The secondary objective of the study is to evaluate immunogenicity, or the vaccine’s ability to provoke an immune response, measured as neutralizing antibody, mucosal IgA, and cellular immune responses. COVI-VAC is stable outside of the ultralow temperature freezers. Providing protection after one dose would simplify logistics and eliminate the risk people will fail to return to get their second shot.

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