Description:
Chikungunya virus (CHIKV) is mosquito-borne alphavirus endemic in Africa, India, and Southeast Asia. In 2013 CHIKV infection has also emerged in the Caribbean and a pandemic of CHIKV has re-emerged in the Philippines following Typhoon Haiyan. Currently, there is no vaccine available for the prevention of CHIKV infection and no specific therapy exists to treat the illness. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) have developed a CHIKV Viral Like Particle (CHIKV VLP) vaccine based on plasmid expression vectors encoding structural proteins of the CHIKV virus, which gave rise to CHIKV VLPs in transfected cells. The CHIKV VLPs consist of the core, E1 and E2 proteins and are similar in buoyant density and morphology to replication-competent CHIKV virus. Immunization with CHIKV VLPs elicited neutralizing antibodies against envelope proteins from different CHIKV strains in mouse and nonhuman primate (NHP) models. Monkeys immunized with CHIKV VLPs produced high titer neutralizing antibodies that protected against viremia after high dose challenge. The selected CHIKV VLP vaccine candidate, VRC-CHKVLP059-00-VP, composed of the E1, E2, and capsid proteins from the CHIKV strain 37997, was recently evaluated by the VRC at the NIH Clinical Center for safety, tolerability and immunogenicity in the clinical protocol VRC 311 (ClinicalTrials.gov # NCT01489358), a Phase I, open-label, dose escalation clinical trial. The VRC-CHKVLP059-00-VP vaccine was highly immunogenic, safe, and well-tolerated. VRC researchers have also developed the transient transfection manufacturing process for CHIKV and other alphaviruses, such as Western, Eastern and Venezuelan Equine Encephalitis (WEVEE) viruses. Pre-clinical in vivo mouse and NHP data, Phase 1 clinical trial data and manufacturing data are available.
NIH will evaluate a license applicant's capabilities and experience in advancing similar technologies through the regulatory process. This technology is not eligible for the NIH's start-up license program.