CyanVac has announced the initiation of a Phase 2b clinical study of CVXGA intranasal COVID-19 vaccine shortly after the company announced results from its Phase 2a trial. The Phase 2b trial, which is expected to enroll 10,000 participants, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and will be conducted by the BARDA clinical studies network.
According to CyanVac, the trial will initially enroll 400 participants, and the remaining 9600 will be enrolled following approval by an independent data and safety monitoring board. The study will evaluate the efficacy of CVXGA versus an mRNA vaccine for the prevention of symptomatic and asymptomatic COVID-19 over 12 months following vaccination.
CyanVac CEO Biao He commented, “This phase 2b trial represents a major milestone for our proprietary PIV5-based vaccine platform. Recently we reported positive results from an earlier Phase 2a trial of CVXGA involving 227 adult volunteers. We expect this new Phase 2b trial to play a key role in confirming these results and validating the potential of our PIV5-based vaccine platform.”
Read the CyanVac press release.