Vimkunya (Chikungunya Vaccine, Recombinant) / Emergent Biosolutions, National Institute of Allergy and Infectious Diseases, Bavarian Nordic - LARVOL DELTA

Vimkunya vaccine approved to prevent disease caused by the chikungunya virus in people 12 years of age and older (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today (1 May 2025) approved a vaccine (Vimkunya) used to prevent disease caused by the chikungunya virus in people 12 years of age and older...This vaccine has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients....As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review."

MHRA approval • Chikungunya

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination (clinicaltrials.gov) - P3 | N=800 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting

Enrollment closed • Chikungunya • Infectious Disease

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. (PubMed, Lancet) - P3 | "Vimkunya induces a rapid and robust immune response. These findings support the potential for this vaccine to protect individuals aged 12-64 years from disease caused by chikungunya virus."

Journal • P3 data • Chikungunya • Fatigue • Musculoskeletal Pain • Pain

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. (PubMed, Lancet) - P3 | "We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up."

Journal • P3 data • Chikungunya

Bavarian Nordic Announces Acceptance of Marketing Authorization Application for Chikungunya Vaccine in the UK for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic...announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the Company’s 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."

MHRA filing • Chikungunya

Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic A/S...today announced that the European Commission has granted marketing authorization in Europe for VIMKUNYA for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older....The approval, valid in all EU member states, as well as in Iceland, Liechtenstein, and Norway....Bavarian Nordic also recently submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) with potential approval of the chikungunya vaccine in the UK in the first half of 2025....Bavarian Nordic will launch VIMKUNYA in key European markets in the first half of 2025....The marketing authorization was granted...based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older."

EMA approval • Launch Europe • MHRA filing • Chikungunya

Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic...announced today that the U.S. Food and Drug Administration (FDA) has approved VIMKUNYA (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older....The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older....Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025."

FDA approval • Launch US • Chikungunya • Infectious Disease

Bavarian Nordic Receives Positive CHMP Opinion for Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "First chikungunya vaccine recommended by the CHMP for persons as young as 12 years old.The virus-like particle (VLP) single-dose chikungunya vaccine is expected to launch in key European markets in the first half of 2025, pending final marketing authorization...After accelerated assessment, the CHMP’s recommendation is primarily based on results from two phase 3 clinical trials...The European Commission...will review the CHMP recommendation and is expected to make a final decision in the coming months...Bavarian Nordic will now also submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP), with potential approval of the chikungunya vaccine in the UK in the first half of 2025.The vaccine is also currently under priority review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for February 14, 2025."

CHMP • EMA approval • Launch Europe • MHRA approval • MHRA filing • PDUFA • Chikungunya

Chikungunya Virus-like Particle Vaccine Induces Cross-Neutralizing Antibodies Against All Three Chikungunya Genotypes and Other Alphaviruses (ASTMH 2024) - "The chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate (known previously as PXVX0317) is a single intramuscular dose comprising three recombinant CHIKV structural proteins derived from the West African CHIKV Senegal strain 37997 formulated with aluminum hydroxide adjuvant...Peak neutralization titers against the four CHIKV strains were observed at 21 days post-vaccination, suggesting that a single dose of CHIKV VLP vaccine can induce cross-protective serum neutralizing antibody (SNA) against all 3 genotypes. As expected, CHIKV VLP vaccine was able to induce cross-neutralizing antibodies against the closely related arthritogenic alphaviruses tested, with the highest titers observed against ONNV and the lowest against RRV but was unable to induce neutralizing antibodies against either encephalitic alphavirus, EEEV or WEEV."

Chikungunya • CNS Disorders

Chikungunya vaccine development, challenges, and pathway toward public health impact. (PubMed, Vaccine) - "Five chikungunya vaccine candidates (BBV87 - BBIL/IVI, MV-CHIK - Themis Bioscience, ChAdOx1 Chik - University of Oxford, PXVX0317 / VRC-CHKVLP059-00-VP - Bavarian Nordic, and mRNA-1388 - Moderna) are in development...This could partly be facilitated through obtaining consensus on scientific and regulatory principles for initial vaccine introduction and generating evidence on chikungunya burden and disease awareness among populations at risk. Specifically, this article advocates for the formation of a global chikungunya vaccine consortium that includes regulators, policymakers, sponsors, and manufacturers to assist in overcoming the global and local challenges for chikungunya vaccine licensure, policy, financing, demand generation, and access to at-risk populations."

Journal • Review • Chikungunya • Infectious Disease

Immunogenicity and Safety of Chikungunya Vaccines: A Systematic Review and Meta-Analysis. (PubMed, Vaccines (Basel)) - "We performed a meta-analysis to estimate the immunogenicity and safety of all chikungunya vaccines that have been progressed to clinical trial evaluation (VLA1553; mRNA-1388/VAL-181388; PXVX0317/VRC-CHKVLP059-00-VP; ChAdOx1 Chik; MV-CHIK). Overall, the present findings support the potential use of the candidate vaccines for the prevention of chikungunya and the current indication for use in adult travelers to endemic regions of the licensed VLA 1553 vaccine. In order to extend chikungunya vaccination to a wider audience, further studies are needed on individuals from endemic countries and frail populations."

Journal • Retrospective data • Review • Chikungunya

Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure. (PubMed, BioDrugs) - "These vaccines use messenger RNA-lipid nanoparticles, inactivated virus, and viral vector approaches, with a live-attenuated vaccine VLA1553 and a virus-like particle PXVX0317 in phase III testing. The European Medicine Agency is considering accelerated assessment review of PXVX0317, with potential for approval by both agencies in 2025. In this review, we summarize published data from pre-clinical and clinical trials for the IXCHIQ and PXVX0317 vaccines. We also discuss unanswered questions including potential impacts of pre-existing chikungunya virus immunity on vaccine safety and immunogenicity, whether long-term immunity can be achieved, safety in children, pregnant, and immunocompromised individuals, and vaccine efficacy in people with previous exposure to other emerging alphaviruses in addition to chikungunya virus."

Journal • Preclinical • Review • Chikungunya • Immunology • Rheumatology

Bavarian Nordic Initiates Rolling Submission of Biologics License Application with FDA for its Chikungunya Vaccine Candidate (GlobeNewswire) - "Bavarian Nordic A/S...announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Bavarian Nordic will submit additional data over the coming months, aiming to complete the BLA submission before the end of the first half of 2024 to support a potential FDA approval of the vaccine in the first half of 2025....the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate, which Bavarian Nordic plans to submit by mid-2024."

BLA • European regulatory • Chikungunya • Infectious Disease

A Phase 3 Clinical Trial to evaluate PXVX0317, a virus-like particle vaccine for active immunization to prevent disease caused by chikungunya virus. (clinicaltrialsregister.eu) - P3 | N=3150 | Sponsor: Bavarian Nordic A/S

New P3 trial • Chikungunya • Infectious Disease

CHIKV VLP: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (clinicaltrials.gov) - P3 | N=3258 | Completed | Sponsor: Bavarian Nordic | Trial primary completion date: Nov 2022 ➔ Apr 2023

Trial primary completion date • Chikungunya

Safety and Immunogenicity of a 40 μg Adjuvanted Dose of a Chikungunya Virus Virus-Like Particle (CHIKV VLP) Vaccine: Results from Three Phase 2 Clinical Trials (ASTMH 2023) - "A single 40μg dose of the adjuvanted CHIKV VLP vaccine, PXVX0317, was well tolerated in three phase 2 clinical trials, including in prior recipients of a heterologous alphavirus vaccine, and generated a rapid SNA response which persisted for 2 years. Phase 3 studies of a 40μg dose of PXVX0317 are ongoing."

Clinical • P2 data • Chikungunya • Fatigue • Musculoskeletal Pain • Pain

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Bavarian Nordic | Not yet recruiting ➔ Recruiting | Trial completion date: May 2028 ➔ Aug 2028

Enrollment open • Trial completion date • Chikungunya • Infectious Disease

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years (clinicaltrials.gov) - P3 | N=413 | Completed | Sponsor: Bavarian Nordic | Active, not recruiting ➔ Completed

Trial completion • Chikungunya

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Bavarian Nordic

New P3 trial • Chikungunya • Infectious Disease

A chikungunya virus-like particle vaccine induces broadly neutralizing and protective antibodies against alphaviruses in humans. (PubMed, Sci Transl Med) - P2 | "Epitope mapping and cryo-electron microscopy defined two broadly neutralizing mAbs that uniquely bind to the apex of the B domain of the E2 glycoprotein. These results demonstrate the inhibitory breadth and activity of the human B cell response induced by the PXVX0317 vaccine against CHIKV and potentially other related alphaviruses."

Journal • Chikungunya • Infectious Disease • Musculoskeletal Diseases

CHIKV VLP: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (clinicaltrials.gov) - P3 | N=3258 | Completed | Sponsor: Emergent BioSolutions | Active, not recruiting ➔ Completed | Trial primary completion date: Mar 2023 ➔ Nov 2022

Trial completion • Trial primary completion date • Chikungunya

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years (clinicaltrials.gov) - P3 | N=413 | Active, not recruiting | Sponsor: Emergent BioSolutions | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date • Chikungunya

CHIKV VLP: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (clinicaltrials.gov) - P3 | N=3258 | Active, not recruiting | Sponsor: Emergent BioSolutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Chikungunya

CHIKV VLP: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (clinicaltrials.gov) - P3 | N=3150 | Recruiting | Sponsor: Emergent BioSolutions | Trial completion date: Nov 2022 ➔ Jul 2023 | Trial primary completion date: Jun 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Chikungunya

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Emergent BioSolutions | Not yet recruiting ➔ Recruiting

Enrollment open • Chikungunya