Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure
− Over 20,000 study participants in dengue-endemic areas in
− Results demonstrated overall vaccine efficacy of 80.2% (12-month follow-up after second dose) against virologically confirmed dengue; exploratory analyses of secondary endpoints showed 82.2% vaccine efficacy among baseline seropositives and 74.9% vaccine efficacy among baseline seronegatives; the vaccine candidate was generally well tolerated with no important safety risks observed to date
− Formal assessment of secondary efficacy endpoints (18-month follow-up after second dose) will be presented later this year; safety and efficacy will be assessed over a total of four and a half years
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Takeda's new dengue vaccine manufacturing plant in Singen,
Takeda’s dengue vaccine candidate was generally well tolerated, and no important safety risks have been observed to date. The observed safety profile was consistent with results reported in previous studies of TAK-003.1,2,3,4 The TIDES trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.
“The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalization,” said
“According to the
Dengue virus infections caused by all four serotypes were observed in the global TIDES trial. Exploratory analyses of secondary endpoints showed efficacy varied by serotype: 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 too few dengue serotype 4 virus cases to fully assess efficacy at this time (VE: 63.2% [95% CI: -64.6% to 91.8%]).
Further analyses of exploratory endpoints also showed that, for both serotypes 1 and 2, efficacy levels among seropositives and seronegatives were similar. For dengue serotype 3, VE in baseline seropositives was 71.3% (95% CI: 54.2% to 82.0%), and in seronegatives, results were inconclusive but suggested a lack of efficacy (VE: -38.7% [95% CI: –335.7% to 55.8%]). No dengue serotype 4 cases were observed in seronegative participants.
While in the process of publishing the primary endpoint data, Takeda received additional data from the ongoing TIDES trial, which adds six months of follow-up and provides formal assessment of the secondary efficacy endpoints. Both the primary endpoint analysis and formal assessment of secondary endpoints will be presented at the
“We are excited to share this long-anticipated data from our TIDES trial, which is evaluating the performance of our dengue vaccine candidate in a diverse set of countries across
The Phase 3 TIDES trial is ongoing, and longer-term data will be important in determining the efficacy and safety profile, particularly in baseline seronegative participants with dengue serotype 3 virus. Takeda is engaging global health experts to provide insights into the burden of dengue in endemic regions and analyses of results from the trial. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.
About the Phase 3 TIDES (DEN-301) Trial
The double-blind, randomized, placebo-controlled Phase 3 TIDES trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.5 Study participants were randomly assigned to receive either TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and Day 90.5 The study is comprised of three parts. The primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 15 months after the first dose (12 months after the second dose).5 The second part of the study continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and severity.5 The final part of the study evaluates VE and long-term safety by following participants for an additional three years.5
The trial is taking place at sites in dengue-endemic areas in
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.6 Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well tolerated.1,2,3,4
Dengue is the fastest spreading mosquito-borne viral disease and is one of the World Health Organization’s top 10 threats to global health in 2019.7,8 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.7 The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.7,9 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.7
Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental U.S. and
Takeda’s Commitment to Vaccines
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.13 For the past 70 years, Takeda has supplied vaccines to protect the health of people in
For more information, visit https://www.takeda.com.
1 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
2 Osorio JE, et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in
3 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 64th Annual Meeting,
4 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
5 ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). 2019. Retrieved
6 Huang CY-H, et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for Tetravalent Dengue Vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243. Retrieved
9 GuzmanMG et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16. Retrieved
10 KnowltonK, et al. Mosquito-Borne Dengue Fever Threat Spreading in the
11 Chan E, et al. Using Web Search Query Data to Monitor Dengue Epidemics: A New Model for Neglected Tropical Disease Surveillance. PLoS Negl Trop Dis. 20115:e1206. Retrieved
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