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A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

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Trial Profile

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2025

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At a glance

  • Drugs VRC-CHKVLP059-00-VP (Primary) ; Aluminium hydroxide
  • Indications Chikungunya virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Bavarian Nordic

Most Recent Events

  • 22 Jul 2025 According to a Bavarian Nordic media release, Health Canada has accepted for review company's application and screening acceptance by the Directorate confirms that New Drug Submission is complete and begins a standard review procedure, supporting approval of the vaccine in the first half of 2026. This submission is based on the data, which also supported the recent US, EU and UK approvals of the vaccine, including results from two phase 3 clinical trials (EBSI-CV317-005 and CHIKV VLP)
  • 02 May 2025 According to a Bavarian Nordic media release, company announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older.
  • 02 May 2025 According to a Bavarian Nordic media release, The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 (NCT05072080 and NCT05349617) clinical trials.

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