Valneva Chikungunya Vaccine VLA-1553 Description
Valneva SE's VLA1553 is a monovalent, single dose, live-attenuated chikungunya vaccine candidate. The VLA1553 vaccine is based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a significant gene encoding the non-structural replicase complex protein nsP3 protection against various Chikungunya virus outbreak phylogroups and strains.
Valneva's VLA1553 is currently the only chikungunya vaccine candidate in clinical development, showing fully sustained titers one year after a single vaccination.
The VLA1553 vaccine candidate is designed for prophylactic, active, single-dose immunization against Chikungunya in humans over 1-year-old. The vaccine targets long-lasting protection and an anticipated safety profile similar to licensed vaccines for active immunization in adults and children.
Valneva reported positive topline results from a Phase 3 pivotal trial on August 5, 2021. The clinical trial, involving over 4,000 adults across 44 sites in the U.S., met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot. VLA1553 was also found generally well-tolerated among the 3,082 subjects evaluated for safety. The trial will continue towards the final analysis, including the 6-month safety data. Final trial results are expected within the next six months.
Chikungunya is a mosquito-borne viral infection spreading in the Americas and Europe, caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes, says the U.S. CDC.
Valneva Chikungunya Vaccine VLA-1553 History
The vaccine program was granted Fast Track designation by the U.S. FDA in December 2018. And on October 16, 2020, announced that the European Medicines Agency (EMA) had granted PRIority MEdicines (PRIME) designation. According to the U.S CDC, this vaccine's target population segments are travelers, military personnel, and individuals at risk living in endemic regions. In addition, the sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher.
To make VLA1553 also accessible to Low and Middle-Income Countries, Valneva and the Butantan Institute in Brazil signed a binding term sheet in May 2020 to develop, manufacture, and market VLA1553. The collaboration will be effective upon the signing of definitive agreements. It will fall within the $23.4 million funding framework Valneva received from the Coalition for Epidemic Preparedness Innovations in July 2019.
During the first half of 2020, VLA1553's complete Phase 1 data were published in the peer-reviewed medical journal The Lancet Infectious Diseases. The Lancet paper provides a detailed analysis of the unique Phase 1 results, which served as a basis for the Company's End of Phase 2 meeting with the U.S. FDA, and enabled the direct progression into Phase 3 study.
On September 8, 2020, the Company announced the initiation of a pivotal Phase 3 clinical trial (VLA1553-301) for its differentiated, single-shot chikungunya vaccine candidate VLA1553a phase 3 study. This study is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 study comprising approximately 4,000 participants aged 18 years or above randomized in a 3:1 ratio to the live-attenuated CHIKV vaccine candidate (VLA1553) or placebo. The study will be conducted at multiple sites across the U.S. The final dose of lyophilized VLA1553 or placebo will be administered as a single intramuscular immunization.
VLA1553 would expand Valneva's existing travel vaccine portfolio, and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. In addition, market research indicates that the global vaccine market against Chikungunya will exceed $500 million annually by 2032.
Saint-Herblain, France-based Valneva (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company providing prevention against diseases with major unmet medical needs.
Valneva Chikungunya Vaccine VLA-1553 Indication
A mosquito-borne viral infection is spreading in the Americas and Europe, caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. Chikungunya fever, a disease caused by the chikungunya virus, reemerged and affected over 52,000 people in southern Thailand in 2008 and 2009. This CHIKV strain involved in this outbreak was the East Central South African (ECSA) strain with the E1-A226V mutation.
Chikungunya disease, which results in incapacitating arthralgia, has been reported worldwide. In addition, a Togaviridae virus is a mosquito-borne alphavirus circulating predominantly in tropical and subtropical regions, potentially affecting over 1 billion people. Before 2013, chikungunya virus cases and outbreaks were identified in Africa, Asia, Europe, and the Indian and Pacific Oceans. In late 2013, the first local transmission of the chikungunya virus in the Americas in Caribbean countries and territories. The expansion of the geographical distribution of the Aedes vector has been a significant contributor to the increases in CHIKV infections during the last decades. Recently, an outbreak began in the western hemisphere.
The Chikungunya virus is a frequent cause of outbreaks among alphaviruses in different geographic locations. It is characterized by fever and joint inflammation, often accompanied by persistent joint pain and arthralgia for several months after initial infection, leading to joint immobilization.
The Chikungunya virus causes clinical illness in 72-92% of infected humans around 4 to 7 days after an infected mosquito bite. Complications from the disease include visual, neurological, heart, and gastrointestinal manifestations; fatalities have been reported (case fatality rates of 0.1% to 4.9% from epidemics) in elderly patients at higher risk.
As of mid-December 2021, 16 chikungunya virus disease cases have been reported in 2021 to the U.S. CDC. The ECDC recently reported about 185,000 Chikungunya cases had been reported in 2021, the majority from Brazil and India. The WHO's online case reporting is available at this link. And the WHO/PAHO says 'There is no preventive vaccine or antiviral drug treatment for Chikungunya. Instead, treatment is focused on relieving the symptoms.'
Valneva Chikungunya Vaccine VLA-1553 Dosage
VLA1553 is administered intramuscularly. At professional clinical trial centers in Illinois and Alabama, USA, healthy volunteers aged 18–45 years were randomly assigned (1:1:2) to one of three escalating groups (low dose 3·2 × 10^3 per 0·1 mL; medium dose 3·2 × 10^4 per 1 mL; or high dose 3·2 × 10^5 50% tissue culture infection dose per 1 mL) and received a single-shot immunization on day 0. Individuals in all groups were revaccinated with the highest dose on either month 6 or 12 and followed for 28 days after revaccination.
Valneva SE Financial News - (Nasdaq: VALN; Euronext Paris: VLA)
November 18, 2021 - Valneva SE reported total revenues were €69.8 million in the first nine months of 2021 compared to €58.8 million in the first nine months of 2020.
November 1, 2021 - Valneva SE announced that the underwriters of its global offering have fully exercised their option to purchase up to 675,000 additional new ordinary shares in the form of 337,500 ADSs. As a result, the total gross proceeds of the Global Offering is approximately $102.0 million (€88.0 million).
October 29, 2021 - Valneva confirmed the aggregate gross proceeds from its offering are expected to be approximately $88.7 million before deducting underwriting commissions and estimated expenses payable by the Company.
October 26, 2021 - Valneva SE announced its intention to issue and sell, subject to market conditions, 5,500,000 of its ordinary shares in a global offering. Approximately $60 million could be used to complete the development of its Chikungunya VLA1553 vaccine candidate through BLA approval.
August 31, 2021 - Analyst Rating: Will Valneva SE ADR (VALN) Stock Lead the Market?
March 24, 2021 - Valneva published its 2020 Annual Business Report online. The report features a video address from CEO Thomas Lingelbach commenting on Valneva's 2020 performance.
Valneva Chikungunya Vaccine VLA-1553 News
December 21, 2021 - Valneva SE announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination. The lot-to-lot trial will continue towards the final six-month analysis, with final trial results expected in the second quarter of 2022. Lot-to-lot trials demonstrate manufacturing consistency, one of the standard requirements for vaccine licensure.
November 15, 2021 - Valneva SE announced it would present its Chikungunya vaccine candidate, VLA1553, on November 18 and 19, 2021, during the American Society of Tropical Medicine & Hygiene 2021 Annual Meeting.
August 21, 2021 - The International Journal of Infectious Diseases published a study: Seroprevalence and associated risk factors of Chikungunya, dengue, and Zika in eight districts in Tanzania, Africa. A total of 1,818 participants (median age = 34 years) were recruited. The overall CHIKV seroprevalence was 28.0%. CHIKV prevalence was highest in Buhigwe (46.8%). In addition, fever was significantly associated with increased odds of CHIKV seropositivity (p < 0.001).
August 19, 2021 - Labiotech.eu reported the results of the phase III trial revealed that a single dose of the live attenuated vaccine developed by Valneva induced the production of neutralizing antibodies in 98.5% of volunteers out of a total of 4,115 people.
August 10, 2021 - Valneva SE reported financial results as of June 30, 2021. At the beginning of August 2021, Valneva announced positive topline results for the Phase 3 pivotal trial of VLA1553. Additionally, VLA1553 was also highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as a similarly good safety profile.
August 7, 2021 - The International Journal of Infectious Diseases published a study: Transient transmission of Chikungunya virus in Singapore exemplifies successful mitigation of severe epidemics in a vulnerable population. Four distinct groups of CHIKV of East, Central, and South African genotype have circulated since 2008, transmitted primarily by Aedes albopictus. The age-weighted CHIKV IgG prevalence rates were low (1-5%) and showed a non-significant increase from 2009 to 2013, but a significant decrease in 2017. In contrast, the prevalence of CHIKV neutralizing antibodies in the population increased significantly from 2009 to 2013, with no substantial change in 2017, but the levels remained below 2%.
August 5, 2021 - Valneva SE announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. The study involved 4,115 adults across 44 sites in the USA, met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single vaccine dose. The seroprotection rate result of 98.5% exceeded the 70% threshold (for non-acceptance) agreed with the U.S. FDA. The seroprotective titer was agreed with the FDA to serve as a surrogate of protection that can be utilized in a potential FDA submission of VLA1553 under the accelerated approval pathway. The vaccine candidate was highly immunogenic with a GMT of approximately 3,270, confirming the immunogenicity profile seen in the Phase 1 trial. Additionally, VLA1553 was also highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as a similarly good safety profile.
July 7, 2021 - Valneva SE announced that it had been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the U.S. FDA.
July 5, 2021 - Professor Thomas Jelinek, renowned key opinion leader and Medical Director of Berlin Centre for Travel and Tropical Medicine, will present chikungunya disease and the Phase 1 study results of Valneva's single-shot chikungunya vaccine candidate VLA1553.
June 23, 2021 - Valneva confirmed that it expects to announce topline data for the Phase 3 trials of its single-shot chikungunya vaccine candidate this summer (2021).
June 10, 2021 - Valneva SE announced that it had completed recruitment for the clinical lot-to-lot consistency Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553: 410 participants aged 18 to 45 years have been randomized in the Phase 3 trial VLA1553-302 and will be followed for a total of six months.
May 20, 2021 - The Company announced 'Excellent progress on clinical programs in the first quarter of 2021. Recruitment completion for pivotal Phase 3 trial.'
May 6, 2021 - Valneva SE announced today the pricing of its initial public offering on the Nasdaq Global Select Market. The aggregate gross proceeds are expected to be approximately $93.5 million, equivalent to about €77.9 million, before deducting underwriting commissions and estimated expenses payable by the Company.
April 12, 2021 - Valneva SE announced that it had completed recruitment for the pivotal Phase 3 trial, VLA1553-301, of its single-shot chikungunya vaccine candidate, VLA1553. As a result, the sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher. A total of 4,131 adults aged 18 or above have been recruited across 44 sites in the USA for VLA1553-301, which was launched in September 2020. If the trial results are positive, the trial is expected to support VLA1553's licensure in the USA.
April 10, 2021 – Valneva SE ("Valneva" or the "Company"), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with a significant unmet medical need, announces today the publication of its 2020 Universal Registration Document filed with the French Financial Markets Authority on April 9, 2021, under the filing number D.21-0286.
March 23, 2021 - GAVI reported 'the deadly combination of climate change and globalization makes chikungunya another mosquito-borne disease a pandemic threat, as mosquitoes find new habitats and increased travel can mean that people bring new diseases into their country.'
February 25, 2021 - Valneva Reports FY 2020 Results and Major Corporate Achievements: Only Phase 3 chikungunya vaccine program to date worldwide; Potentially eligible for Priority Review Voucher – for the first Company to receive Biologics License Application approval. Thomas Lingelbach, Chief Executive Officer, commented, "With over €200 million of cash, Valneva is in a strong position to continue to focus on execution of our key programs, which could result in an even greater transformation in 2021 and beyond."
February 22, 2021 - Valneva SE announced that it had initiated the clinical lot-to-lot consistency Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553. This study aims to show the manufacturing consistency of the vaccine by demonstrating that three consecutively manufactured lots elicit equivalent immune responses measured by neutralizing antibody titers on Day 29 after vaccination. This study will run parallel to the ongoing, pivotal Phase 3 study, VLA1553-301, which determines seroprotection based on an immunological surrogate.
January 25, 2021 - Valneva SE and Instituto Butantan announced the signing of definitive agreements for developing, manufacturing, and marketing Valneva's single-shot chikungunya vaccine, VLA1553, in Low and Middle-Income Countries (LMICs). This finalization follows the signing of a binding term sheet in May 2020. The collaboration falls within the framework of the $23.4 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations in July 2019.
November 3, 2020 - To make VLA1553 accessible to Low and Middle-Income Countries, Valneva and the Butantan Institute in Brazil signed a binding term sheet in May 2020 to develop, manufacture, and market VLA1553. The collaboration will be effective upon the signing of definitive agreements. It will fall within the $23.4 million funding framework Valneva received from the Coalition for Epidemic Preparedness Innovations in July 2019.
October 16, 2020 - Valneva SE announced that the European Medicines Agency (EMA) had granted PRIority MEdicines designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553. This new designation from the EMA complements the Fast Track designation received by the U.S. FDA in December 2018.
September 30, 2020 - Health officials in Chad have reported an outbreak of Chikungunya. The Abéché health district (Ouaddaï Region) is reporting the most cases; the health districts of Biltine (Wadi Fira Region) and Abdi (Ouaddaï Region) are also reporting cases.
September 30, 2020 - Chikungunya is an ongoing risk in many parts of Africa, and there is currently an outbreak in Ethiopia. Travelers should protect themselves by preventing mosquito bites.
September 8, 2020 - Valneva SE announced the initiation of a pivotal Phase 3 clinical trial for its differentiated, single-shot chikungunya vaccine candidate VLA1553, the first chikungunya vaccine Biologics License Application to be approved in the U.S. would be eligible to receive a Priority Review Voucher.
August 4, 2020 - Valneva announced it is currently advancing all necessary activities, including its Contract Research Organization, and intends to initiate the pivotal Phase 3 study in the fourth quarter of 2020, as planned.
June 1, 2020 - A new study published in The Lancet found the live-attenuated CHIKV vaccine was well tolerated and highly immunogenic in an adult population and could be an effective intervention for prophylaxis chikungunya disease worldwide.
May 7, 2020 - Valneva Reports Q1 Results and Updates 2020 Guidance. As previously announced, the Company assumes that it may start Phase 3 clinical studies in the fourth quarter of this year, three months later than initially planned. Accordingly, Valneva is advancing all activities, including its Contract Research Organization (CRO), to allow Phase 3 initiation as soon as the COVID-19 situation permits.
May 5, 2020 - Valneva SE and Instituto Butantan announced signing a binding term sheet for developing, manufacturing, and marketing Valneva's single-shot chikungunya vaccine VLA1553 in Low Middle-Income Countries (LMICs). In addition, Valneva held its End of Phase 2 meeting with the U.S. Food and Drug Administration in February 2020 and is now preparing to initiate Phase 3 clinical studies in the U.S. later in 2020.
March 25, 2020 – Valneva SE announced that it has completed an End-of-Phase 2 meeting with the U.S. FDA and agreed on the clinical development plan towards licensure for its unique, single-shot chikungunya vaccine VLA1553.
January 24, 2020 - The Company assumes that it may start Phase 3 in the fourth quarter of 2020, representing approximately a 3 to 6 months delay than its original plans.
January 7, 2020 – An End Of Phase 2 meeting was scheduled with the U.S. Food and Drug Administration on February 24, 2020, for the chikungunya vaccine candidate VLA1553.
November 18, 2019 - Final Phase, one results up to Month 13, confirm the excellent immunogenicity and safety profile for VLA1553, its single-shot vaccine candidate. After a single vaccination, the final results showed an excellent immunogenicity profile in all vaccinated dose groups. In addition, a 100 percent seroconversion was achieved on Day 14 after a single vaccination in all dose groups, and titers were sustained at 100 percent at Month 12.
December 21, 2018: VLA1553 was granted Fast Track designation by the US Food and Drug Administration.
Valneva Chikungunya Vaccine VLA-1553 Clinical Trials
Valneva continues to test VLA-1553 Chikungunya Vaccine in various clinical trials.