1. Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination
- Author
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Felix Espinoza, Edson D. Moreira, Inge Lefevre, Maria Theresa Alera, Asvini D. Fernando, Mengya Liu, Delia Yu, Pope Kosalaraksa, Luis Rivera, Vianney Tricou, Martina Rauscher, Hector Velásquez, Pujitha Wickramasinghe, Dulanie Gunasekera, Derek Wallace, Lulu Bravo, Luis Martinez Vargas, Xavier Sáez-Llorens, Rivaldo Venâncio da Cunha, Veerachai Watanaveeradej, Astrid Borkowski, Charissa Borja-Tabora, Kleber Giovanni Luz, Edith Johana Rodriguez-Arenales, Chukiat Sirivichayakul, Reynaldo Dietze, Shibadas Biswal, Humberto Reynales, Eduardo López-Medina, and LakKumar Fernando
- Subjects
0301 basic medicine ,Serotype ,medicine.medical_specialty ,Adolescent ,030106 microbiology ,Dengue Vaccines ,Antibodies, Viral ,Vaccines, Attenuated ,Placebo ,Dengue fever ,Dengue ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,030212 general & internal medicine ,Child ,Adverse effect ,Dengue vaccine ,business.industry ,Vaccination ,Dengue Virus ,medicine.disease ,Antibodies, Neutralizing ,Infectious Diseases ,Child, Preschool ,business ,Serostatus ,Efficacy Study - Abstract
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.
- Published
- 2020