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A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents

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Trial Profile

A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs VRC-CHKVLP059-00-VP (Primary) ; Adjuvants
  • Indications Chikungunya virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms CHIKV VLP
  • Sponsors Bavarian Nordic; Emergent BioSolutions

Most Recent Events

  • 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
  • 07 Mar 2025 According to a Bavarian Nordic media release, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the Companys single-dose chikungunya vaccine, CHIKV VLP vaccine, for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older

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