Takeda’s Dengue Vaccine Candidate Associated with Reduced Incidence of Dengue in Children and Adolescents; New 18-Month Interim Phase 2 Data Published in The Lancet Infectious Diseases
Takeda Pharmaceutical Company Limited (TSE: 4502), (“Takeda”) today announced that data from an 18-month interim analysis of the ongoing Phase 2 DEN-204 trial of its live, attenuated tetravalent dengue vaccine candidate, TAK-003 (also referred to as TDV), have been published in The Lancet Infectious Diseases . The results of this interim analysis, a pre-planned evaluation of data from an ongoing trial, show that TAK-003 is associated with a reduction in the incidence of dengue in children and adolescents.1 These data were also presented today at the American Society of Tropical Medicine and Hygiene Annual Meeting.3 Phase 3 data are required to confirm these findings.
The Phase 2 DEN-204 trial is ongoing and evaluating the safety and immunogenicity of TAK-003 in 1,794 children and adolescents ages 2 through 17 living in dengue-endemic areas (the Dominican Republic, Panama and the Philippines). The primary objective of the trial is to assess the vaccine-induced antibody levels to all four types of dengue virus following different vaccine schedules.4 Trial participants received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or a placebo.1 Febrile surveillance and assessment of safety and immunogenicity will continue through the 48-month study period of the trial.1
These interim results showed:1
- In the safety set (the group of participants who received at least one dose of TAK-003 or placebo), children and adolescents who received TAK-003 had a relative risk of symptomatic dengue of 0.29 (95% CI: 0.13–0.72) compared to children and adolescents in the placebo control group. Incidence of dengue was a pre-specified secondary endpoint of the analysis.1
- TAK-003 was found to be safe and well-tolerated in terms of solicited local reactions and systemic adverse events, relative to the placebo control group. This is consistent with data from previous Phase 1 and 2 studies.1
- The immune response against all four dengue serotypes was durable across all vaccinated groups, with antibody levels persisting out to 18 months regardless of vaccine schedule or previous exposure to the dengue virus.1
- There was limited difference in geometric mean titers (GMTs) and seropositivity rates between those who received one primary dose and those who received two primary doses three months apart, regardless of serostatus. However, importantly, in participants who were seronegative at baseline, a second dose given at Month 3 improved the tetravalent seropositivity rate at Month 6 to 86%, compared to 69% in the one-dose group.1 A booster dose at Month 12 resulted in a 100% tetravalent seropositivity rate at Month 13 in participants who were seronegative at baseline.1
These findings support selection of a two-dose regimen, administered three months apart, for Takeda’s ongoing global pivotal Phase 3 efficacy trial. This regimen quickly achieves a high rate of response to all four dengue serotypes regardless of previous dengue exposure.1
“We are seeing an acceptable safety profile and sustained antibody responses out to 18 months in this trial. These data are an important step in the development of our dengue vaccine candidate,” said Derek Wallace, M.B.B.S., Global Dengue Program Lead at Takeda.1 “The reduced incidence of dengue in children and adolescents receiving TAK-003 is encouraging, however data from our ongoing Phase 3 efficacy trial, TIDES, are required to confirm these findings.”1
TAK-003 is currently under evaluation in the Tetravalent Immunization against Dengue Efficacy Study (TIDES), a large-scale Phase 3 efficacy trial being conducted in eight dengue-endemic countries.2 TIDES will build on DEN-204 and other previous studies in continuing to assess the tolerability, safety and immunogenicity of the vaccine against all four dengue serotypes in multiple age groups and to determine whether the vaccine helps prevent symptomatic dengue.2, 5, 6 Data from TIDES will be available in late 2018.2
About the Phase 2 DEN-204 Trial
The Phase 2 DEN-204 trial is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the safety and immunogenicity of either one- or two-dose schedules of TAK-003 in 1,794 healthy participants living in dengue-endemic areas (the Dominican Republic, Panama and the Philippines).7
Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live, attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four vaccine viruses.8 Phase 1 and 2 data have supported progression into Phase 3 study, suggesting that TAK-003 is safe and well-tolerated in children and adolescents (no vaccine-related SAEs occurred and reactogenicity was limited) and induced immunogenicity against all four dengue serotypes, even in seronegative participants. 7, 9, 10, 11
Dengue is the fastest spreading mosquito-borne viral disease.12 Dengue is spread by Aedes aegypti and Aedes albopictus mosquitoes and is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.13, 14 The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.15, 16
Dengue outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental U.S. and Europe.13, 17, 18 Approximately half of the world now lives under the threat of dengue, which is responsible for approximately 390 million infections and 20,000 deaths globally each year.13, 19 Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.13
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health.20 For 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, Zika, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
1. Sáez-Llorens, X., Tricou, V., et al. Immunogenicity and safety of one versus two doses of tetravalent dengue vaccine in healthy children aged 2–17 years in Asia and Latin America: 18-month interim data from a phase 2, randomised, placebo-controlled study. Lancet Infectious Diseases. 2017. Retrieved November 2017.
2. ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). 2017. Retrieved October 2017.
3. Wallace, D. et al. Progress in Development of Takeda’s Tetravalent Dengue Vaccine Candidate. 2017. Presented at 66th Annual Meeting, American Society of Tropical Medicine and Hygiene.
4. ClinicalTrials.gov. Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants. 2017. Retrieved October 2017.
5. ClinicalTrials.gov. A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers. 2017. Retrieved October 2017.
6. ClinicalTrials.gov. Safety and Immunogenicity With Two Different Serotype 2 Potencies of Tetravalent Dengue Vaccine (TDV) in Adults in Singapore. 2017. Retrieved October 2017.
7. Sáez-Llorens, X., Tricou, V., et al. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine: Interim results of a long-term phase 2, randomized, placebo-controlled pediatric trial in Asia and Latin America. The Lancet Infectious Diseases. 2017. Retrieved October 2017.
8. Huang, C. Y.-H., et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for Tetravalent Dengue Vaccine (DENVax). PLoS Neglected Tropical Diseases. 2013. Retrieved May 2016.
9. Osorio, J.E., et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. The Lancet Infectious Diseases. 2014. Retrieved May 2016.
10. Wallace, D. Persistence of neutralizing antibodies one year after two doses of a candidate recombinant tetravalent dengue vaccine in subjects aged from 1.5 to 45 years. Presented at 6th Annual Meeting, American Society of Tropical Medicine and Hygiene. 2015.
11. Saez-Llorens, X., et al. Phase II, double-blind, controlled trial to assess the safety and immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and <18 years and living in dengue endemic countries in Asia and Latin America. Presented at 5th Pan-American Dengue Research Network Meeting. 2016.
12. World Health Organization. Vector-borne diseases fact sheet. 2014. Retrieved August 2017.
13. World Health Organization. Dengue and Severe Dengue. 2016. Retrieved January 2017.
14. Centers for Disease Control and Prevention. Clinical Guidance Dengue Virus. 2014. Retrieved January 2017.
15. Bravo, L., et al. Epidemiology of Dengue Disease in the Philippines (2000-2011): A Systematic Literature Review. PLoS Neglected Tropical Diseases. 2014. Retrieved January 2017.
16. Guzman, M.G., et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010. Retrieved May 2016.
17. Knowlton, K., et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved May 2016.
18. Chan E., et al. Using Web Search Query Data to Monitor Dengue Epidemics: A New Model for Neglected Tropical Disease Surveillance. PLoS Neglected Tropical Diseases. 2011. Retrieved January 2017.
19. Murray N.E., et. al. Epidemiology of dengue: past, present and future prospects. Clinical Epidemiology. 2013. Retrieved August 2017.
20. UNICEF. Immunization Facts and Figures. 2013. Retrieved January 2017.
Takeda Pharmaceutical Company Limited
For media outside of Japan:
Elissa J. Johnsen
TEL: + 1 224-554-3185
For Japanese media:
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 201818.7.2018 20:21 | Tiedote
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, will be presenting over 20 abstracts, including data from the landmark GEMINI 1 & 2 clinical trials, at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, in Amsterdam, The Netherlands. The data being presented this year has a strong focus on novel exploratory therapeutic options and innovative treatment strategies, as well as improving awareness and understanding of key issues that continue to affect the HIV community. John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we see advancements in the treatment options available to people living with HIV, our research efforts over the past few years have been focused on moving beyond viral load and addressing some of the unresolved issues that people living with HIV face, such as the potential long-term risks and toxicities that can be associated with li
Xilam: H1 2018 Revenue: +50%18.7.2018 19:00 | Tiedote
Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t
Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 15:38 | Tiedote
The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign
Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 15:05 | Tiedote
Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d
Sterigenics Expands European Capacity With New State-of-the-Art Gamma Sterilization Facility in the UK18.7.2018 15:00 | Tiedote
Sterigenics, a Sotera Health company and leading global provider of mission-critical sterilization solutions and expert advisory services, announced today it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK. The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global HealthTM. Scheduled for completion in the fourth quarter, 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000-square-foot facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire. “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, President of Ste
Smiths Detection Technology Chosen for Standard 3 Upgrade at Helsinki Airport18.7.2018 12:05 | Tiedote
Smiths Detection has been selected by Finnish airport operator, Finavia Corporation, to support the transition to Standard 3 at Helsinki Airport with approved hold baggage screening systems. Included in the contract are eight high-speed, HI-SCAN 10080 XCT scanners, which combine high resolution X-ray technology, computed tomography (CT) and advanced detection algorithms to increase both security and operational efficiency significantly. Security, speed and efficiency are critical to the extensive development programme underway at the airport, which will allow the airport to serve 30 million passengers annually and increase baggage handling capacity by 50%. “Any financial investment in upgrading security equipment has to be balanced against operational improvement, particularly when part of a major expansion. Airports need assurance that efficiencies will be gained and systems can be further updated as necessary to detect evolving explosive threats and handle ever higher volumes,” comme
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme