Valneva Chikungunya Vaccine VLA-1553 Description 2022
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 (CHIKV) 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.
Valneva reported positive topline results from a Phase 3 pivotal clinical trial VLA1553-301 on August 5, 2021, which enrolled 4,115 adults across 44 sites in the U.S., and met all primary and secondary endpoints. The final analysis announced on March 8, 2022, confirmed the very high level of seroprotection, with 98.9% of participants achieving protective levels of CHIKV neutralizing antibodies one month after receiving a single vaccination (263 of 266 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.7-99.8). In addition, the immunogenicity profile was maintained over time, with 96.3% of participants showing protective CHIKV neutralizing antibody titers six months after receiving a single vaccination (233 of 242 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 93.1-98.3). VLA1553 was also highly immunogenic in elderly study participants (65 years of age or older), who achieved equally high seroprotection rates and neutralizing antibody titers over time as younger adults. The reported seroprotection levels far exceeded the 70% threshold (for non-acceptance) based on a surrogate of protection agreed with the U.S. FDA under the accelerated approval pathway.
On May 5, 2022, Valneva confirmed the Coalition for Epidemic Preparedness Innovations (CEPI) funded the phase 3 study, and the trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in a chikungunya endemic region. The Company previously reported positive topline lot-to-lot manufacturing consistency trial results for VLA1553. This is one of the standard requirements for vaccine licensure, and final lot-to-lot results are expected in the second quarter of 2022.
The WHO/PAHO says, 'There is no preventive vaccine or antiviral drug treatment for Chikungunya. And as of June 16, 2022, the U.S. FDA had not authorized a CHIV vaccine.
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 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.
The vaccine program was granted Fast Track designation by the U.S. FDA in December 2018. During the first half of 2020, VLA1553's complete Phase 1 data were published in the peer-reviewed medical journal The Lancet Infectious Diseases. And on October 16, 2020, Valneva 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.
Chikungunya disease, which results in incapacitating arthralgia, has been reported worldwide. 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. Brazil's southwest, where São Paulo and Rio de Janeiro are located, presented a higher incidence with 29,700 cases of Chikungunya, including 14,300 cases in São Paulo compared to 281 last year.
CHIKV 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. CHIKV 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 were reported in 2021 to the U.S. CDC. The ECDC reported the majority of cases had been reported by Brazil (92,349), and all deaths were reported from Brazil in 2022.
VLA1553 is administered intramuscularly. At clinical trial centers in Illinois and Alabama, U.S., 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)
August 11, 2022 - Product sales of the Company's travel vaccine franchise are expected to reach €70 million to €80 million in 2022.
May 5, 2022 - Valneva's total revenues were €21.8 million in the first quarter of 2022 compared to €23.2 million in 2021.
April 26, 2022 - Valneva SE announced an agreement to increase the principal amount of its existing $60 million debt financing agreement. The increased funding will further invest in R&D, including market access preparations for the chikungunya vaccine candidate, VLA1553.
February 3, 2022 - The Company confirmed 2021 revenues include €94.8 million of product and other revenues (excluding COVID).
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.
Chikungunya Vaccine VLA-1553 News For 2018 - 2022
August 11, 2022 - Valneva confirmed the single-dose Chikungunya Vaccine Candidate VLA1553 initiation of rolling submission for Biologics License Application with the U.S. FDA imminent, final positive pivotal Phase 3 results reported, and final positive lot-to-lot consistency Phase 3 results reported.
July 30, 2022 - In a follow-up on the chikungunya situation in Brazil this year, the Pan American Health Organization (PAHO) reports Brazil has seen 186,170 total cases, including 75,505 confirmed cases through July 16. Additionally, 40 deaths have been recorded.
June 7, 2022 - Valneva SE announced it would present on June 9, 2022, at the 8th Northern European Conference on Travel Medicine an update on its single-shot chikungunya vaccine candidate VLA1553.
June 2, 2022 - The PAHO reported 113,052 CHIVK cases, and 14 deaths have been reported.
May 31, 2022 - Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva, commented, "Dr. Decker and Dr. Pfleiderer's significant expertise will be highly complementary to that of the existing Scientific Advisory Board. We look forward to having them join this advisory group, whose skills and perspectives are extremely valuable to Valneva as we continue to enhance our future R&D strategy."
May 25, 2022 - Valneva SE announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. With a 96.0% seroprotection rate at Day 180, the immunogenicity profile from study VLA1553-301 was also confirmed.
May 12, 2022 - PLOS Medicine reported on a cohort study during the years 2014-2018 examining the incidence of chikungunya virus infections among children hospitalized with neurological disease in Kilifi County, coastal Kenya.
May 5, 2022 - The Company confirmed it initiated a Phase 3 trial in adolescents in January 2022. The trial is conducted in Brazil by Instituto Butantan.
March 24, 2022 - Valneva confirmed the ongoing development of a single-dose vaccine candidate against the chikungunya virus, a mosquito-borne virus spread to over 120 countries.
March 8, 2022 - Valneva SE announced the successful completion of Phase 3 pivotal trial of VLA1553. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021. Valneva now expects to commence the pre-submission process with the U.S. FDA in the second quarter of 2022.
January 31, 2022 - Valneva SE announced a Phase 3 clinical trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553. Instituto Butantan is conducting the VLA1553-321 is a double-blinded, multi-center, randomized, and placebo-controlled Phase 3 trial in Brazil with 750 adolescents aged 12 to 17 years who will be randomized at a 2:1 ratio to receive either VLA1553 or placebo.
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.
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 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.
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.
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.
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.
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. FDA 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 toward licensure for its unique, single-shot chikungunya vaccine 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.
VLA-1553 Clinical Trials
Valneva continues to test VLA-1553 Chikungunya Vaccine in various clinical trials.
VLA1553-301 Phase 3 trial was initiated in September 2020. It is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 trial evaluating 4,115 participants aged 18 years or above. Lyophilized VLA1553 or placebo was administered as a single intramuscular immunization. The primary objective of the trial was to evaluate the immunogenicity and safety of VLA1553 at one month following a single immunization.
Conducted in Brazil by Instituto Butantan, VLA1553-321 is a double-blinded, multi-center, randomized, and placebo-controlled Phase 3 trial. 750 adolescents aged 12 to 17 years will be randomized at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity following a single vaccination with VLA1553. Participants will be evaluated after 28 days and followed up to twelve months. The study will also provide safety and immunogenicity data in participants previously exposed to Chikungunya.