Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination


Eduardo López-Medina, Universidad del Valle, Cali
Shibadas Biswal
Xavier Saez-Llorens, Hospital del Niño Dr. José Renán Esquivel
Charissa Borja-Tabora, Gokila
Lulu Bravo, University of the Philippines Manila
Chukiat Sirivichayakul, Faculty of Tropical Medicine, Mahidol University
Luis Martinez Vargas, Centro de Atención e Investigación Médica
Maria Theresa Alera, Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit
Hector Velásquez, Centro de Atención e Investigación Médica
Humberto Reynales, Centro de Atención e Investigación Médica
Luis Rivera, Hospital Maternidad Nuestra Señora de la Altagracia
Veerachai Watanaveeradej, Phramongkutklao College of Medicine
Edith Johana Rodriguez-Arenales, Centro de Atención e Investigación Médica
Delia Yu, De La Salle Medical and Health Sciences Institute
Felix Espinoza, National Autonomous University of Nicaragua
Reynaldo Dietze, Federal University of Espirito Santo
Lak Kumar Fernando, Negombo General Hospital
Pujitha Wickramasinghe, University of Colombo
Edson Duarte Moreira, Fundacao Oswaldo Cruz
Asvini D. Fernando, University of Kelaniya
Dulanie Gunasekera, University of Sri Jayawardenenpura
Kleber Luz, Universidade Federal do Rio Grande do Norte
Rivaldo Venâncio da Cunha, Universidade Federal de Mato Grosso do Sul
Vianney Tricou, Takeda Pharmaceuticals International AG
Martina Rauscher, Takeda Pharmaceuticals International AG
Mengya Liu
Inge LeFevre, Takeda Pharmaceuticals International AG
Derek Wallace
Pope Kosalaraksa, Faculty of Medicine, Khon Kaen University
Astrid Borkowski, Takeda Pharmaceuticals International AG

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The Journal of infectious diseases


BACKGROUND: Takeda's dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update. METHODS: Children (20 099, 4-16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR. RESULTS: Cumulative efficacy against dengue approximately 27 months since first dose was 72.7% (95% confidence interval [CI], 67.1%-77.3%), including 67.0% (95% CI, 53.6%-76.5%) in dengue-naive and 89.2% (95% CI, 82.4%-93.3%) against hospitalized dengue. In the second year, decline in efficacy was observed (56.2%; 95% CI, 42.3%-66.8%) with the largest decline in 4-5 year olds (24.5%; 95% CI, -34.2% to 57.5%); efficacy was 60.6% (95% CI, 43.8%-72.4%) in 6-11 year and 71.2% (95% CI, 41.0%-85.9%) in 12-16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to efficacy differences in year-by-year analysis. No related serious adverse events occurred during the second year. CONCLUSIONS: TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further.Clinical Trials Registration. NCT02747927.Takeda's tetravalent dengue vaccine (TAK-003) continued to demonstrate benefit in reducing dengue independent of baseline serostatus up to 2 years after completing vaccination with some decline in efficacy during the second year in 4-16 year olds in dengue-endemic countries.

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