Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination. (15th December 2020)

• Record Type: Journal Article
• Authors: López-Medina, Eduardo; Biswal, Shibadas; Saez-Llorens, Xavier; Borja-Tabora, Charissa; Bravo, Lulu; Sirivichayakul, Chukiat; Vargas, Luis Martinez; Alera, Maria Theresa; Velásquez, Hector; Reynales, Humberto; Rivera, Luis; Watanaveeradej, Veerachai; Rodriguez-Arenales, Edith Johana; Yu, Delia; Espinoza, Felix; Dietze, Reynaldo; Fernando, Lak Kumar; Wickramasinghe, Pujitha; Duarte Moreira, Edson; Fernando, Asvini D; Gunasekera, Dulanie; Luz, Kleber; da Cunha, Rivaldo Venâncio; Tricou, Vianney; Rauscher, Martina; Liu, Mengya; LeFevre, Inge; Wallace, Derek; Kosalaraksa, Pope; Borkowski, Astrid
• Is Part Of: Journal of infectious diseases. Volume 225:Number 9(2022)
• Page Start: 1521
• Page End: 1532
• Publication Date: 2020-12-15
• Subjects: dengue -- vaccine -- TAK-003 -- efficacy -- immunogenicity -- safety -- persistence; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiaa761
• Languages: English
• ISSNs: 0022-1899

Abstract

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.