Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: YES) (Takeda) today announced that the primary endpoint analysis is based on the ongoing Phase 3 Key Tetravalent Immunization Against Dengue Efficacy Study (TIDES) on its dengue vaccine candidate (YES) -003) in New England Journal of Medicine have been published. Takeda dengue vaccine candidate provided protection against virologically confirmed dengue fever (VCD), which was the primary endpoint of the study in children aged 4 to 16 years. Vaccine (VE) efficacy was 80.2 percent (95% confidence interval) [KI]: 73.3% to 85.3%; p <0.001) within 12 months after the second dose given three months after the first dose. In planned exploratory secondary endpoint analyzes, protection was found to be the same regardless of whether recipients were previously infected with dengue fever (VE: 82.2%). [95% KI: 74,5% bis 87,6%] or VE: 74.9% [95% KI: 57,0% bis 85,4%]). Further exploratory analysis showed a 95.4% reduction in the number of hospitalizations associated with dengue fever (95% CI: 88.4% to 98.2%). Due to the limited number of cases, efficacy in the course of severe disease could not be established. Protection began after the first dose and VE was 81% between the first and second doses (95% CI: 64.1% to 90.0%).
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The new Takeda dengue vaccine production plant is based in Singen, Germany. (Photo: Business Wire)
Takeda's dengue vaccine candidate was generally well tolerated and no significant safety risk has been observed so far. The observed safety profile was consistent with the results reported in previous studies TAK-003.1,2,3,4 The safety and efficacy of the vaccine will continue to be assessed through the TIDES study for a total of 4.5 years.
"The results of this preliminary analysis are very encouraging because they indicate that the vaccine has the potential to provide significant public health benefits in terms of dengue and hospitalization," said Dr. med. Dr. Humberto Reynales, main author New England Journal of Medicine published article. "Further analysis of test results over time is important to determine the efficacy and safety of the vaccine in the long term. If observation data confirm these first results in the long term, we have taken a significant step forward in the global fight against dengue fever. "
"According to the World Health Organization, dengue fever is one of the top 10 health threats in the world. That is why it is extremely important to have a safe and effective vaccine candidate who can reduce the devastating effects of dengue fever in areas where the disease is endemic. " In-Kyu Yoon, Senior Advisor, International Vaccine Institute. "In the past, developing a dengue vaccine has proved difficult, especially for people who have not been exposed to dengue fever, but these results show protection against dengue fever, even those who did not have dengue fever."
The effectiveness depends on the serotype
During the global TIDES study, dengue infections caused by all four serotypes were observed. Exploratory analysis of secondary endpoints showed that the efficacy varied between serotypes: VE was 73.7% for serotype 1 (95% CI: 51.7% to 85.7%), 97.7% for serotype 2 (95 % CI: 92.7% to 99.3%) and 62.6% for serotype 3 (95% CI: 43.3% to 75.4%). There were currently too few cases of serotype 4 virus to determine efficacy (VE: 63.2%). [95% KI: -64,6% bis 91,8%]).
Further analysis of exploratory endpoints also showed similar efficacy in seropositive and seronegative patients for serotypes 1 and 2. In serotype 3 dengue, vaccine efficacy at the beginning was seropositive in 71.3 percent (95% CI: 54.2% for 82.0%) , while the results were not conclusive in seronegative individuals, but suggested a lack of efficacy (SU: -38.7%). [95% KI: –335,7% bis 55,8%]). There were no cases of serotype 4 dengue fever in seronegative volunteers.
Prior to the release of the primary endpoint data, Takeda received additional data from the ongoing TIDES study that will extend the observation period by six months and provide a formal assessment of the secondary efficacy endpoints. The results of the primary endpoint analysis and formal assessment of the secondary endpoints will be presented at the 68th Annual Meeting of the American Society for Tropical Medicine and Sanitation (ASTMH) held November 20-24, 2019 in National Harbor, Maryland and sent for publication in peer-reviewed journal.
"We are pleased to announce these highly anticipated data from our TIDES study, which will test the performance of our dengue vaccine candidate in various Asian and Latin American countries, with a high percentage of children among those who have not had contact with dengue fever," explained Dr. Med. Rajeev Venkayya, president, Global Vaccine Business Unit, Takeda. "Although we need more data to fully understand the safety and efficacy profile of TAK-003, these results strongly suggest that the drug can reduce the huge global burden of dengue fever in all populations. We look forward to providing more data over the next few weeks and discussing the results and priorities of future data collection with Health Authorities and researchers, practitioners and medical communities, as well as on how we can work together to understand the extent and the impact of the vaccine to make the most of it after it has been approved. "
The TIDES phase 3 study is ongoing and long-term data are important in determining the vaccine efficacy and safety profile, especially at the beginning of the study in seronegative individuals with dengue virus serotype 3. Takeda uses global health professionals to gain insight into the burden of dengue fever in regions where this disease is endemic, and research results need to be reviewed. The dengue vaccine candidate developed by Takeda is currently not approved in any country in the world.
Information about the TIDES phase 3 test phase (DEN-301)
In a double-blind, randomized and placebo-controlled phase 3 trial, TIDES will assess the safety and efficacy of two doses of TAK-003 in preventing laboratory-confirmed, symptomatic dengue fever of any severity due to one of four dengue virus serotypes in children and adolescents,5 Patients were randomized on days 1 and 90 with subcutaneous injection of 0.5 ml TAK-003 or placebo.5 The study consists of three parts. In the primary endpoint analysis, the efficacy (VE) and safety of the vaccine were assessed within 15 months of the first dose (12 months after the second dose).5 Part 2 was continued for a further six months, during which the evaluation of the effectiveness of the secondary vaccine efficacy by serotype, initial severity and severity was completed.5 The final part of the study assesses the efficacy and long-term safety of the vaccine by monitoring participants for the next three years.5
The study will be conducted at locations in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where dengue fever is endemic and there is a high unmet medical need for dengue prevention because this disease is present main cause of serious illness and death among children.5 Blood samples were taken from all study participants at the start of the study to assess efficacy and safety based on their serological status. Takeda and an independent data monitoring committee with experts ensure continuous active security monitoring.
The tetravalent candidate for dengue vaccine Takeda (TAK-003) is based on an attenuated live vaccine against dengue serotype 2 virus, which is a genetic skeleton? represents all four vaccine viruses.6 Data from phase 1 and 2 studies in children and adolescents showed that TAK-003 induces an immune response to all four dengue serotypes in both seropositive and seronegative participants. The vaccine was generally safe and well tolerated.1,2,3,4
About dengue fever
Dengue fever is the fastest growing mosquito-borne viral disease, and according to the World Health Organization, one of the top ten health threats in the world in 2019.7.8 Dengue fever is mainly caused by mosquitoes of the genus Aedes aegypti and, to a lesser extent, through Aedes albopictus transmitted and caused by one of four dengue virus serotypes that can cause dengue fever or dengue fever, respectively.7 The frequency of some serotypes varies depending on geographical conditions, country, region and season, and over longer periods.7.9 Recovery after serotype infection provides lifelong protection only to the same serotype. Subsequent exposure to one of the other serotypes is associated with an increased risk of serious disease progression.7
Dengue fever can cause pandemics, and outbreaks are observed in tropical and subtropical areas. There have also been recent outbreaks in parts of the United States and Europe.7,10,11 About half of the world's population is currently at risk of dengue fever, which is estimated to cause 390 million infections and 20,000 deaths annually worldwide.7.12 The dengue virus can infect people of all ages and is a major cause of childhood diseases in some Latin American and Asian countries.7
About Takeda's involvement in vaccines
Vaccines prevent 2 to 3 million deaths each year and have changed global health.13 Takeda has been supplying vaccines for Japanese protection for 70 years. Today, the global vaccine business of Takeda is innovating to combat some of the most serious infectious diseases in the world, such as dengue fever, Zika virus and norovirus. Our team has a unique history and in-depth knowledge of vaccine development and production, as well as global access to a range of vaccines to meet the world's most urgent health needs. For more information, please visit www.TakedaVaccines.com.
Information about Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: YES) is a global, value-based, leading research and development group for biopharmaceuticals based in Japan. He sees his mission to help patients achieve better health and a more positive future by acquiring highly innovative drugs from scientific research. Takeda's research and development work focuses on four therapeutic areas: oncology, gastroenterology (GI), rare diseases and neuroscience. We also invest part of our research and development budget in therapies including plasma derivatives and vaccines. We focus on developing highly innovative drugs that help effectively improve people's quality of life. We are opening new treatment options, using our strengthened, synergistic research area and our joint capabilities to create a solid, multimodal pipeline. Our employees are committed to improving the quality of life of patients and cooperate with our healthcare partners in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
1 Sáez-Llorens X, Tricou V, et al. Safety and immunogenicity of the Takeda tetravalent dengue vaccine: interim results of a long-term, randomized, placebo-controlled pediatric phase 2 study in Asia and Latin America. Lancet Infect Dis, 2017; 17: 615-625. Available in October 2019.
2 Osorio JE et al. Safety and immunogenicity of recombinant live attenuated tetravalent dengue vaccine (DENVax) in healthy adults not previously treated with flavivirus in Colombia: a randomized, placebo-controlled phase 1 study. Lancet Infect Dis, 2014; 14: P830-838. Available in October 2019.
3 Wallace D. Stability of neutralizing antibodies one year after two doses of one candidate recombinant tetravalent dengue vaccine in people aged 1.5 to 45 years. Lecture at the 64th annual meeting, American Society of Tropical Medicine and Hygiene; October 2016; Philadelphia, Pa.
4 Saez-Llorens X, et al. Takeda & # 39; s Tetravalent Dengue Vaccine Candidate (TDV) in healthy people aged 2 to <18 years old and living in endemic dengue countries in Asia and Latin America. Lecture at the 5th Pan-American Dengue Research Network; April 2016; Galveston, Texas.
5 ClinicalTrials.gov. Efficacy, safety and immunogenicity of the Takeda tetravalent vaccine (TDV) in healthy children (TIDES). 2019. Access in October 2019.
6 Huang CY-H et al. Genetic and phenotypic characterization of production seeds for the tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013; 7: E2243. Available in October 2019.
7 World Health ORganisation. Sheet. Dengue and heavy dengue. April 2019. Access in October 2019.
8 World Health ORganisation. Ten threats to global health in 2019 and 2019. Access in October 2019.
9 Guzman MG et al. Dengue: A continuous global threat. Nature Microbiology Reviews, 2010; 8: S7-S16. Available in October 2019.
10 Knowlton et al. The threat transmitted by dengue mosquitoes is spreading throughout the Americas. Council for the Protection of Natural Resources (NRDC). 2009. Available in October 2019.
11 Chan E et al. Use of search query data to monitor dengue outbreaks: a new model for monitoring neglected tropical diseases. PLoS Negl Trop Dis, 20115: E1206. Available in October 2019.
12 World Health ORganisation. Sheet. Dengue. 2019. Access in October 2019.
13 UNICEF. Vaccination and vaccination statistics. 2019. Access in October 2019.
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