Themis Bioscience announced that the Food and Drug Administration (FDA) has granted Fast Track designation to MV-CHIK, a vaccine candidate based on the measles vector, for the prevention of chikungunya.
The safety, tolerability and immunogenicity of MV-CHIK was evaluated in a phase 2 double-blind, randomized, placebo- and active-controlled trial (NCT02861586). Results showed that neutralizing antibodies against the virus were detected in all treatment arms after 1 or 2 immunizations; seroconversion rates ranged from 50%–95.9%, depending on dose and vaccination schedule in the per-protocol population (N=247). In addition, pre-existing antibodies against the measles vaccine virus were not found to impact the immunogenicity against chikungunya.
“The FDA decision to grant fast track designation to MV-CHIK, recognizes the urgency to prevent this disease and will greatly support our pivotal phase 3 development efforts this year,” stated Erich Tauber, CEO of Themis Bioscience.
There are currently no approved treatments or vaccines available for chikungunya, a virus transmitted through mosquito bites. In 2018, an investigational chikungunya virus-like particle (VLP) vaccine was granted Fast Track status for the prevention of disease caused by the virus.
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