January 25, 2021 -- Medigen Vaccine Biologics and Dynavax Technologies have dosed the first participant in a phase II clinical trial evaluating Medigen's COVID-19 vaccine candidate, MVC-COV1901, a subunit vaccine with a recombinant spike-2P antigen adjuvanted with Dynavax's CpG 1018.
The spike-2P antigen is a trimeric and prefusion stable recombinant protein developed by the U.S. National Institutes of Health (NIH). Medigen has obtained the global technology license for spike-2P from the U.S. Vaccine Research Center at NIH. The new study is based on positive phase I interim data demonstrating a good safety profile and encouraging immunogenicity of the vaccine candidate.
The phase II trial, located in Taiwan, is a randomized, double-blinded, multicenter trial expected to enroll 3,700 healthy subjects, 20 years of age and older. It will evaluate safety and immunogenicity with a dosing regiment of two intramuscularly administered doses one month apart.