Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure :: Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents :: Takeda Unveils New Dengue Vaccine Manufacturing Plant in Germany

Milestones :: Perspectives :: Research

 

Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure
November 06, 2019
− New England Journal of Medicine publishes primary endpoint analysis from ongoing Phase 3 study of Takeda’s dengue vaccine candidate
− Over 20,000 study participants in dengue-endemic areas in Latin America and Asia received two doses of Takeda’s dengue vaccine candidate or placebo administered three months apart
− 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

… “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 Humberto Reynales, M.D., Ph.D., a lead author of the New England Journal of Medicine paper. “It will be important to further analyze the trial results over time in order to assess the long-term efficacy and safety of the vaccine. If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue.”

“According to the World Health Organization, dengue represents one of the ten biggest global health threats, and it is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact dengue fever has in endemic regions,” said In-Kyu Yoon, M.D., Senior Advisor, International Vaccine Institute. “Historically, vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to dengue, and these results demonstrate protection from dengue fever, including among many participants without prior dengue.”…

 

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New England Journal of Medicine
November 6, 2019
DOI: 10.1056/NEJMoa1903869
Original Article Free Preview
Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents
Shibadas Biswal, M.D., Humberto Reynales, M.D., Ph.D., Xavier Saez-Llorens, M.D., Pio Lopez, M.D., Charissa Borja-Tabora, M.D., Pope Kosalaraksa, M.D., Chukiat Sirivichayakul, M.D., Veerachai Watanaveeradej, M.D., Luis Rivera, M.D., Felix Espinoza, M.D., LakKumar Fernando, M.D., Reynaldo Dietze, M.D., Kleber Luz, M.D., Rivaldo Venâncio da Cunha, M.D., José Jimeno, M.D., Eduardo López-Medina, M.D., Astrid Borkowski, M.D., Ph.D., Manja Brose, M.Sc., Martina Rauscher, Ph.D., Inge LeFevre, M.D., Svetlana Bizjajeva, Ph.D., Lulu Bravo, M.D., and Derek Wallace, M.B., B.S. for the TIDES Study Group*
Abstract
Background
Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.
Methods
We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype.
Results
Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively).
Conclusions
TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. (Funded by Takeda Vaccines; TIDES ClinicalTrials.gov number, NCT02747927. opens in new tab.)

 

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Takeda Unveils New Dengue Vaccine Manufacturing Plant in Germany
− The manufacturing plant opening marks an important milestone for Takeda’s mission to tackle the global threat of dengue
− The site will be utilized for formulation, fill, finish and secondary packaging of Takeda’s dengue vaccine candidate
− Takeda’s dengue vaccine candidate is currently being evaluated in the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial1
November 05, 2019
SINGEN, Germany–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited today announced the opening of its new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003. The Singen vaccine plant will be utilized for formulation, fill, finish and secondary packaging of the dengue vaccine candidate starting with the packaging line. Takeda invested more than 130 million Euro and will employ up to 200 employees in the vaccine plant…