PaxVax announced that the Food and Drug Administration (FDA) has granted Fast Track designation for its vaccine to prevent disease caused by the chikungunya virus.
A Phase 2b dose-finding trial is underway for the chikungunya virus-like particle (VLP) vaccine following a Phase 2a study (N=400) conducted by the National Institutes of Health. VLP vaccines are multi-protein structures that resemble naturally occurring viruses but do not contain the viral genome and are thus non-infectious. The chikungunya VLP vaccine maintains natural epitopes to mimic natural infection.
The Company plans on enrolling 400 individuals in their Phase 2b study to assess several dosing regimens. Study data are expected to be available in 2019.
“It is exciting to see this vaccine candidate moving forward with Fast Track designation as this is an extremely debilitating disease with the potential for causing serious long term sequelae,” said Eva Harris, PhD Professor, Division of Infectious Diseases and Vaccinology and Director, Center for Global Public Health, University of California, Berkeley.
There are currently no approved treatments or vaccines available for the treatment of chikungunya, a virus transmitted through mosquito bites. Symptoms of chikungunya include headache, muscle pain, skin rashes, and in some cases, severe joint pain that can persist for years.
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