CastleVax initiates Phase 2 trial of CVAX-01 intranasal COVID-19 vaccine

Nasal vaccine developer CastleVax has announced the initiation of a Phase 2 study comparing its CVAX-01 intranasal COVID-19 vaccine to an mRNA-based injectable COVID-19 vaccine. The 6-month study is expected to enroll 200 previously-vaccinated adults with underlying conditions. CastleVax notes that CVAX-01 is already approved in Thailand and has Emergency Use Authorization in Mexico.

In June 2024, the US’s Biomedical Advanced Research and Development Authority (BARDA) announced that it was providing ~$34 million to CastleVax to support a Phase 2b trial in 10,000 participants. According to the new press release, the Phase 2 trial just initiated has received funding from the New York State Biodefense Commercialization Fund.

CastleVax CEO and Chief Scientific Officer Michael A. Egan commented, “This Phase 2 study represents a major step forward towards our goal to develop a next-generation COVID-19 booster vaccine capable of eliciting mucosal immunity and protecting against SARS-CoV-2 breakthrough infection and transmission. Importantly, we expect this Phase 2 trial to validate the potential of our NDV-based vaccine platform to elicit infection blocking mucosal immune responses, allowing for the development of next generation vaccines targeting a wide variety of diseases.”

Read the CastleVax press release

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