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:
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Pacific Drilling Announces Settlement in Mediation Between Quantum Pacific and Ad Hoc Group of Creditors20.8.2018 14:02 | Pressemelding
Pacific Drilling S.A. (OTC:PACDQ) (“Pacific Drilling” or the “Company”) today announced that its plan of reorganization filed on July 31, 2018 (the “Plan”), based on a proposal presented to the Company’s Board of Directors by an ad hoc group of its secured creditors (collectively, the “Ad Hoc Group”), now has the full support of the Company’s majority shareholder, Quantum Pacific (Gibraltar) Limited (“QP”). The Plan was already supported by all of the Company’s major creditor interests. With QP’s participation, the Company expects a smooth plan confirmation process and a quick emergence from its Chapter 11 proceedings. Pacific Drilling CEO Paul Reese commented, “The agreement reached by QP and the Ad Hoc Group delivers the final piece needed to make the Company’s Plan a consensual one that has the support of the Company’s major stakeholders. The agreement should allow the Plan to move forward efficiently and expeditiously through the implementation and confirmation process.” Pursuant t
Bella Hadid Headlines True Religion’s Latest Campaign20.8.2018 12:32 | Pressemelding
True Religion has tapped Bella Hadid to be the face of the brand. The supermodel embodies all things True Religion, past, present and future; iconic, edgy and everlasting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180820005283/en/ Bella Hadid Headlines True Religion’s Latest Campaign (Photo: Business Wire) An inherit fan of the brand, Bella was the natural choice to meld the iconic essence of the brand with the modern view of its future. An all-star team was assembled including photographer Boo George, stylist Mimi Cuttrell, and hair and makeup duo Jen Atkin and Mary Phillips to create imagery and complementary looks that usher True Religion into a new era that honors the heritage of the brand. A quintessential, confident LA girl with roots at home and abroad, Bella’s voice was not only an inspiration, but an integral part in imagining this campaign, envisioning the brand through her eyes for the next generation of True
Veristat Congratulates Alnylam on the FDA Approval of ONPATTRO™ (patisiran)20.8.2018 11:30 | Pressemelding
Veristat, a full service Clinical Research Organization (CRO), congratulates Alnylam on the recent FDA approval of ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. “On behalf of the entire Veristat team that has supported Alnylam in the development of this therapy, we are humbled to have contributed towards this first-in-class drug approval for Alnylam, for the patients with hATTR amyloidosis and their families,” said John P. Balser, Ph.D., President and Co-Founder of Veristat. “We are continuing to support Alnylam as they look to expand regulatory approval of this treatment to other regions of the world.” Veristat began working with Alnylam over 11 years ago and helped design the studies and prepare the Investigational New Drug (IND) submission for patisiran. Our collaboration continued throughout the entire patisiran program inclusive of a phase 2 study, a phase 3 pivotal study
FRISS Brings Claim Fraud Analysis to a Next Level With Web-IQ´s Innovative Online Network Solution20.8.2018 11:30 | Pressemelding
Asking your neighbor or friend to sign as a witness to a claim for car damages at your insurance company will work no more, with the new Claim Fraud Analysis feature of FRISS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180820005039/en/ Eldert van Wijngaarden (Web-IQ) and Philip van Waning (FRISS) shaking hands. (Photo: Business Wire) FRISS, the worldwide provider of AI powered fraud and risk solutions for the P&C insurance industry, recently added a new and innovative feature in their fraud analytics solution: Online Network Analysis from Web-IQ. This feature automatically identifies if the claimants and the insured or other involved persons are related to each other in an on-line environment. This is a proven and strong indicator for fraudulent claims. Especially with car accidents and other types of claims where multiple persons are involved, it adds a whole new approach to the traditional claim analyses. “Research sho
Global IBC Future Zone and IABM Future Trends Theatre to Explore the Latest Tech Shaping the Industry20.8.2018 11:18 | Pressemelding
IBC2018, the world’s most influential media, entertainment and technology show, today announces the line-up for the IBC Future Zone and IABM Future Trends Theatre. Well established as part of the IBC Exhibition, from 14-18 September, the Future Zone brings together the very latest ideas, innovations and concept technologies from international industry and academia and showcases them in a single specially-curated area sitting alongside exhibition Hall 8. This year, the focus is on showing how new technologies grow from their first inception and progress through to research, development, and validation projects; right through to maturing into the ground-breaking applications and future product standards. Major industry trail-blazers presenting their visions of the future, include Japan’s NHK and BBC R&D from the UK. Both companies will demonstrate a number of technology advances, including: Web-VR applications; object-based media scenarios; pathways to 8K resolution for UHD; and Artifici
Ocean Ambassador of the Netherlands Joins Endowment for Clean Ocean’s Entrepreneur Judges Committee20.8.2018 11:07 | Pressemelding
The Endowment for Clean Oceans (ECO) announced Willemijn Peeters, Ocean Ambassador of the Netherlands and the Founding Director of Searious Business has joined ECO’s Entrepreneur Committee that will vet contestants’ plans to remove macro and micro plastics from the world’s oceans. “I am working to solve the problem of what to do with the plastic once it is removed from the ocean, by helping to create a market for plastic recovered from the ocean,” said Peeters. “Just like we need to end the use of single use plastic, we need to replace the manufacture of virgin plastic and replace it with recycled plastics, and as much as possible needs to be plastic recovered from the ocean.” View source version on businesswire.com: https://www.businesswire.com/news/home/20180820005004/en/ Contact information The Endowment for Clean Oceans Daniel Perrin Daniel.Perrin@endowmentforcleanoceans.org or email@example.com