Codagenix Inc -- a US-based clinical-stage synthetic biology company, announced on Tuesday that it has completed dosing of its phase one clinical trial to assess CodaVax-H1N1, a universal, live-attenuated influenza vaccine.
The randomised, double-blind clinical trial is being carried out in Australia and is intended to evaluate the safety, tolerability and immunogenicity of the vaccine in healthy adults 18-49 years of age.
The Phase 1 trial has enrolled 45 patients in total across three cohorts of escalating dose to receive intramuscular vaccinations, with approximately nine patients receiving CovaVax-H1N1 at each dose level, nine patients receiving placebo and nine patients receiving a licensed seasonal influenza comparator vaccine. The primary endpoints of the study are to see reactogenicity and adverse events resulting from vaccination, with a secondary endpoint to evaluate humoral immune responses caused by intramuscular injection with CodaVax-H1N1.
Initial results from this study are likely to be revealed in the fourth quarter of 2022.
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