Ixchiq (VLA1553) / Valneva - LARVOL DELTA

Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ Among U.S. Travelers (GlobeNewswire) - " Valneva SE...today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva’s single-dose chikungunya vaccine IXCHIQ for the prevention of disease caused by the chikungunya virus (CHIKV)....ACIP maintained its current recommendation for IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak....'Valneva is committed to the highest standards of safety, and the safety profile of IXCHIQ remains unchanged and positive.'"

DSMB • Chikungunya

Valneva to Participate in Multiple Events at the 25th World Vaccine Congress, including a Presentation on its Chikungunya Vaccine IXCHIQ (GlobeNewswire) - "Valneva SE...today announced its presence at the forthcoming 25th World Vaccine Congress, which will take place from April 21-24, 2025 at the Walter E. convention center in Washington, D.C. Under the leadership of the Company´s Chief Executive Officer, Thomas Lingelbach, a team of Valneva´s senior managers will participate in multiple events, including an important presentation on the Company´s vaccine IXCHIQ, the world’s first licensed chikungunya vaccine."

Clinical data • Chikungunya

CHIKUNGUNYA: DOSE-RESPONSE PHASE 2 TRIAL TO ASSESS THE SAFETY AND IMMUNOGENICITY OF SINGLE-DOSE LIVE ATTENUATED VACCINE (VLA1553) IN CHILDREN AGED 1 TO 11 YEARS (ESPID 2025) - P2 | "Conclusions/Learning Points Safety and tolerability profile was highly similar for both VLA1553 full and half dose. The more ​pronounced immune response of the full dose compared to half dose supports the choice of the full dose for the pivotal Phase 3 pediatric trial."

Clinical • P2 data • Anorexia • Chikungunya • Infectious Disease • Meningococcal Infections • Pain • Pediatrics

CHIKUNGUNYA: FINAL PHASE 3 SAFETY AND IMMUNOGENICITY 12-MONTH DATA OF VLA1553, A SINGLE-DOSE LIVE-ATTENUATED VACCINE IN ADOLESCENTS IN BRAZIL – A PIVOTAL TRIAL (ESPID 2025) - "Seropositive participants reported less related AEs after VLA1553 compared to seronegatives (52.1% versus 74.3%). Conclusions/Learning Points VLA1553 administered as a single-dose was generally safe and well tolerated, irrespective of previous CHIKV-infection or age group, and induced a robust and persistent immune response in adolescents."

Clinical • P3 data • Chikungunya • Fatigue • Musculoskeletal Pain • Pain

Valneva Receives First Marketing Authorization for IXCHIQ in a Chikungunya Endemic Country (GlobeNewswire) - "Valneva...today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The ANVISA decision marks the world’s first approval of a chikungunya vaccine in an endemic country. Part of Valneva’s endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI), with co-funding from the European Union (EU), and Instituto Butantan2 to support broader access to a chikungunya vaccine in low-and-middle-income countries (LMICs)....Label extension applications to adolescents were submitted in the U.S., Canada and the U.K....This important approval primarily enables initiation of large-scale clinical trials of IXCHIQ in Brazil, including the committed Phase 4 clinical trials supporting IXCHIQ’s approval by the U.S."

Approval • Canada filing • FDA filing • MHRA filing • New P4 trial • New trial • Chikungunya

Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ (GlobeNewswire) - "Valneva SE...today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus, to individuals 12 years of age and older. IXCHIQ received marketing authorization in Europe for individuals 18 years and older in July 2024....The European Commission (EC) will now review the CHMP recommendation, and a decision on the label extension application of IXCHIQ in the European Union (EU), Norway, Liechtenstein and Iceland is expected within sixty days....The positive CHMP opinion is supported by positive six-month adolescent Phase 3 data which Valneva reported in May 2024."

CHMP • Chikungunya

Cross-neutralizing activity of the chikungunya vaccine VLA1553 against three prevalent chikungunya lineages. (PubMed, Emerg Microbes Infect) - P3 | "Moreover, the magnitude of the immune response was similar to the antibody levels detected in sera from convalescent chikungunya patients. Thus, VLA1553 has the potential to diminish the burden of chikungunya disease on a global scale.Trial registration: ClinicalTrials.gov identifier: NCT04546724.."

Journal • Chikungunya

Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook (GlobeNewswire) - "Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023); Key Upcoming Catalysts...Lyme disease Phase 3 first data readout by the end of 2025; Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ in major travel markets; Initiation of Phase 3 pediatric trial of IXCHIQ to support further potential label expansion; Phase 2b efficacy data from Human Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in mid-2025 and launch of pediatric study; Phase 1 results for Zika vaccine candidate in the first half of 2025"

Commercial • New trial • P1 data • P3 data • Chikungunya • Infectious Disease • Lyme Disease

Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ (GlobeNewswire) - "Valneva SE...today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ....The approval is based on IXCHIQ’s final pivotal Phase 3 data, published in The Lancet..."

MHRA approval • Chikungunya • Infectious Disease

A Clinical Phase 3 Trial of VLA1553 in Adult Participants with Human Immunodeficiency Virus (HIV) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Valneva Austria GmbH | N=75 ➔ 0 | Trial completion date: Sep 2025 ➔ Aug 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Jan 2025 ➔ Aug 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Chikungunya • Human Immunodeficiency Virus • Infectious Disease • CD4

Modelling of 5 year antibody persistence after vaccination with Live attenuated Chikungunya vaccine VLA1553 (IXCHIQ®) (ASTMH 2024) - P3 | "These results are encouraging, suggesting that VLA1553 could provide long-term protection against CHIKV, making it a crucial tool for controlling the spread of chikungunya and reducing its public health impact. The ongoing VLA1553-303 clinical trial will be essential to confirm these findings and support the ongoing development of VLA1553."

Late-breaking abstract • Chikungunya • Infectious Disease

Cross-neutralizing antibody responses elicited by the chikungunya vaccine VLA1553 (ASTMH 2024) - P3 | "Finally, we used antigenic cartography to demonstrate vaccinee and infection sera cluster antigenically. These data imply that VLA1553 elicits a cross-nAb breadth that extends to related alphaviruses to a similar potency of CHIKV infection, which may have important cross-protective implications for individuals susceptible to alphavirus cocirculation."

Chikungunya • Infectious Disease

Chikungunya: Phase 3 Safety and Immunogenicity Six-Months Data of VLA1553, a Single-dose Live-attenuated Vaccine in Adolescents in Brazil - a Pivotal Trial (ASTMH 2024) - "These data show that VLA1553 administered as a single-dose was generally safe and well tolerated, irrespective of previous CHIKV-infection, and induced a robust and persistent immune response in adolescents. The findings are expected to support regulatory filings for an extended indication of VLA1553 among adolescents and in endemic areas."

Clinical • Late-breaking abstract • P3 data • Chikungunya • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Chikungunya: Ongoing Dose-Response, Safety, and Immunogenicity Phase 2 Trial of Single-dose Live-attenuated Vaccine (VLA1553) in Children aged 1 to 11 years (ASTMH 2024) - P2, P3 | "Once available, these Phase 2 results will potentially support the initiation of a Phase 3 pediatric pivotal trial with the objective to broaden the IXCHIQ ® label to the age group in the pediatric population. This would follow the initial regulatory licensure obtained in adults and possibly also in adolescents."

Clinical • P2 data • Chikungunya • Infectious Disease • Meningococcal Infections • Pediatrics

Predicting the impact of a potential chikungunya outbreak in Miami and the impact of a chikungunya vaccine (ASTMH 2024) - "Our model results show that an emergency response vaccination program can be effective during a CHIKV outbreak, especially if the outbreak is detected early on and the program is initiated promptly after detection. Future research should explore the applicability of these findings in other locations where Aedes mosquitoes are present."

Chikungunya • Infectious Disease

Cross-neutralizing antibody responses elicited by the chikungunya vaccine VLA1553 (ASTMH 2024) - P3 | "Finally, we used antigenic cartography to demonstrate vaccinee and infection sera cluster antigenically. These data imply that VLA1553 elicits a cross-nAb breadth that extends to related alphaviruses to a similar potency of CHIKV infection, which may have important cross-protective implications for individuals susceptible to alphavirus cocirculation."

Chikungunya • Infectious Disease

Cross-neutralizing antibody responses elicited by the chikungunya vaccine VLA1553 (ASTMH 2024) - P3 | "Finally, we used antigenic cartography to demonstrate vaccinee and infection sera cluster antigenically. These data imply that VLA1553 elicits a cross-nAb breadth that extends to related alphaviruses to a similar potency of CHIKV infection, which may have important cross-protective implications for individuals susceptible to alphavirus cocirculation."

Chikungunya • Infectious Disease

Cost-Effectiveness of Chikungunya Vaccination With IXCHIQ in Adults in Puerto Rico (ISPOR-EU 2024) - "The IXCHIQ vaccination program is cost-effective for adults aged ≥18 years in Puerto Rico, when assessing the likelihood of an outbreak within the next 20 years. The findings support recommending the IXCHIQ vaccine to mitigate the public health impact of CHIKV in this population, with robust results confirmed across multiple analyses."

Clinical • Cost effectiveness • HEOR • Chikungunya

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

Pooled safety evaluation for a new single-shot live-attenuated chikungunya vaccine. (PubMed, J Travel Med) - "A single dose of VLA1553 presented with an excellent local tolerability profile and overall safety in line with that expected for a live-attenuated vaccine. The safety profile was comparable in participants aged 18-64 years and ≥65 years."

Journal • Chikungunya • Musculoskeletal Pain

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

From bench to clinic: the development of VLA1553/IXCHIQ, a live-attenuated chikungunya vaccine. (PubMed, J Travel Med) - "VLA1553 is the first vaccine approved for the prevention of chikungunya disease in adults, following accelerated development based on a serological surrogate marker of protection. VLA1553 adds to strategies to reduce the spread and burden of chikungunya in endemic populations and travellers."

Journal • Chikungunya • Infectious Disease

Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in endemic areas of Brazil: interim results of a double-blind, randomised, placebo-controlled phase 3 trial in adolescents. (PubMed, Lancet Infect Dis) - P3 | "VLA1553 was generally safe and induced seroprotective titres in almost all vaccinated adolescents with favourable safety data in adolescents who were seropositive at baseline. The data support the use of VLA1553 for the prevention of disease caused by the chikungunya virus among adolescents and in endemic areas."

Journal • P3 data • P3 data: top line • Chikungunya • Fatigue • Immunology • Musculoskeletal Pain • Pain • Rheumatology

The Approved Live-Attenuated Chikungunya Virus Vaccine (IXCHIQ®) Elicits Cross-Neutralizing Antibody Breadth Extending to Multiple Arthritogenic Alphaviruses Similar to the Antibody Breadth Following Natural Infection. (PubMed, Vaccines (Basel)) - "The first vaccine against chikungunya virus (CHIKV) was recently licensed in the U.S., Europe, and Canada (brand IXCHIQ®, referred to as VLA1553)...We compared vaccinee responses to cross-nAbs elicited by natural CHIKV infection in individuals living in the endemic setting of Puerto Rico at 8-9 years post-infection. These data suggest that IXCHIQ efficiently and potently elicits cross-nAb breadth that extends to related alphaviruses in a manner similar to natural CHIKV infection, which may have important implications for individuals that are susceptible to alphavirus co-circulation in regions of potential vaccine rollout."

Journal • Chikungunya • Infectious Disease