Ixchiq (VLA1553) / Valneva - LARVOL DELTA

Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in adolescents: final results from a 12-month, double-blind, randomised, placebo-controlled, phase 3 trial in endemic areas of Brazil. (PubMed, Lancet Infect Dis) - P3 | "VLA1553 was generally safe and induced seroprotective titres up to 12 months in nearly all adolescents, with favourable safety data in those who were seropositive. The data support the use of VLA1553 for the prevention of disease caused by the chikungunya virus among adolescents and in endemic regions."

Journal • P3 data • Chikungunya • Fatigue • Immunology • Infectious Disease • Musculoskeletal Pain • Pain • Rheumatology

Acceptability of a chikungunya vaccine and dengue vaccine among travelers in Martinique (French West Indies), for the travel and for their home territory. (PubMed, IJID Reg) - "We evaluated the acceptability of live chikungunya and dengue vaccines (VLA1553 and TAK-003) among users of Martinique's travel clinics from January to April 2025...Few data are available on chikungunya vaccine acceptability. We found similar acceptability for this vaccine in Martinique as reported in the United States Virgin Islands (56%), an overseas territory of the United States in the Caribbean, and in La Réunion, another French overseas territory in the Indian Ocean (60.5% in the hypothetical full-reimbursement scenario)."

Journal • Chikungunya • Dengue Fever • Infectious Disease

Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil (clinicaltrials.gov) - P=N/A | N=5000 | Not yet recruiting | Sponsor: Valneva Austria GmbH

New trial • Chikungunya • Infectious Disease

Chikungunya vaccination for travelers: Practical guidance for clinical decision-making. (PubMed, J Travel Med) - "Knowledge of the profiles and key features of the live attenuated and virus-like particle vaccines will enable healthcare providers to better advise travelers who are considering chikungunya vaccination."

Journal • Chikungunya

Chikungunya: Dose-Response Phase 2 Safety and Immunogenicity Month 6 Data of VLA1553, a Single-Dose Live-Attenuated Vaccine in Children Aged 1 to 11 Years (ASTMH 2025) - P2 | "Among the 304 healthy children randomized 2:2:1 to a single shot of either the half or full dose VLA1553 formulation or control (Nimenrix®, tetravalent meningococcal vaccine), 7.9% had pre-existing CHIKV-specific antibodies. The Month 6 data confirm that the safety and tolerability profile was highly similar for VLA1553 full and half dose. The more pronounced immune response of the full compared to the half dose supports the use of the full dose moving forward."

Clinical • Late-breaking abstract • P2 data • Chikungunya • Infectious Disease • Meningococcal Infections

Modelling of 10-year antibody persistence after vaccination with live-attenuated chikungunya vaccine VLA1553 (IXCHIQ) (ASTMH 2025) - P3 | "These findings support the potential of VLA1553 to provide long-term protection against CHIKV and strengthen its value in public health strategies aimed at mitigating chikungunya outbreaks. Continued follow-up in the VLA1553-303 trial will be essential to validate these projections."

Chikungunya • Infectious Disease

Assessment of Chikungunya Virus Seroprevalence Before VLA1553 Vaccination in the Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil (clinicaltrials.gov) - P=N/A | N=4988 | Enrolling by invitation | Sponsor: Valneva Austria GmbH | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Chikungunya • Infectious Disease

Fatal Adverse Event After VLA1553 Chikungunya Vaccination in an Elderly Patient: A Case Report From Reunion Island. (PubMed, Open Forum Infect Dis) - "This case is the first fatal adverse event officially recognized by French health authorities as plausibly related to VLA1553 vaccine. It raises concerns regarding potential neuroinvasive disease following vaccination in elderly individuals and highlights the importance of close clinical and virological evaluation in post-vaccination adverse events during outbreak settings."

Adverse events • Journal • Acute Kidney Injury • Chikungunya • CNS Disorders • Critical care • Musculoskeletal Pain • Nephrology • Renal Disease

Assessment of Chikungunya Virus Seroprevalence Before VLA1553 Vaccination in the Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil (clinicaltrials.gov) - P=N/A | N=4988 | Not yet recruiting | Sponsor: Valneva Austria GmbH

New trial • Chikungunya • Infectious Disease

VLA1553-221: A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years (clinicaltrials.gov) - P2 | N=304 | Completed | Sponsor: Valneva Austria GmbH | Active, not recruiting ➔ Completed

Trial completion • Chikungunya • Infectious Disease

A Phase 3 Trial to Evaluate the Safety and Immunogenicity of VLA1553 in Healthy Children Aged 1 to 11 Years. (clinicaltrials.gov) - P3 | N=3000 | Not yet recruiting | Sponsor: Valneva Austria GmbH

New P3 trial • Chikungunya • Infectious Disease

Comprehensive Assessment of Reactogenicity and Safety of the Live-Attenuated Chikungunya Vaccine (IXCHIQ®). (PubMed, Vaccines (Basel)) - " In clinical trials, VLA1553 showed an acceptable safety profile that was consistent with other live-attenuated vaccines. The incidence of broad-definition AESIs was mainly limited to the immediate post-vaccination period, and broad-definition AESI symptoms were mostly solicited systemic adverse events."

Journal • Chikungunya • Fatigue • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

UK's MHRA suspends Valneva's chikungunya vaccine for elderly (Yahoo Finance UK) - "UK's medicine regulator said on Monday it has temporarily restricted the use of French vaccine maker Valneva's shot to treat chikungunya, a virus transmitted by mosquitoes, in people aged 65 and above as a precautionary measure. The vaccine, IXCHIQ, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in February to protect people aged 18 years and above against chikungunya, but is not yet available in the UK market." "

European regulatory • Chikungunya • Infectious Disease

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 • Chikungunya • Infectious Disease • Meningococcal Infections

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

Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years. (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: Butantan Institute

New P3 trial • Chikungunya • Dengue Fever

Assessment of the transmission of live-attenuated chikungunya virus vaccine VLA1553 by Aedes albopictus mosquitoes. (PubMed, Parasit Vectors) - "The evidence presented herein argue that the low viraemia in VLA1553-vaccinated individuals would mitigate against transmission. In addition, replication of VLA1553 in mosquito bodies was also significantly attenuated. Overall, mosquito-borne transmission of VLA1553 from vaccinated individuals to others appears improbable."

Journal • Chikungunya • Rheumatology

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

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