Please use this identifier to cite or link to this item: http://repository.kln.ac.lk/handle/123456789/21935
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dc.contributor.authorLópez-Medina, E.
dc.contributor.authorBiswal, S.
dc.contributor.authorSaez-Llorens, X.
dc.contributor.authorBorja-Tabora, C.
dc.contributor.authorBravo, L.
dc.contributor.authorSirivichayakul, C.
dc.contributor.authorVargas, L.M.
dc.contributor.authorAlera, M.T.
dc.contributor.authorVelásquez, H.
dc.contributor.authorReynales, H.
dc.contributor.authorRivera, L.
dc.contributor.authorWatanaveeradej, V.
dc.contributor.authorRodriguez-Arenales, E.J.
dc.contributor.authorYu, D.
dc.contributor.authorEspinoza, F.
dc.contributor.authorDietze, R.
dc.contributor.authorFernando, L.
dc.contributor.authorWickramasinghe, P.
dc.contributor.authorMoreira Jr, E.D.
dc.contributor.authorFernando, A.D.
dc.contributor.authorGunasekera, D.
dc.contributor.authorLuz, K.
dc.contributor.authorda Cunha, R.V.
dc.contributor.authorTricou, V.
dc.contributor.authorRauscher, M.
dc.contributor.authorLiu, M.
dc.contributor.authorLeFevre, I.
dc.contributor.authorWallace, D.
dc.contributor.authorKosalaraksa, P.
dc.contributor.authorBorkowski, A.
dc.contributor.authorTIDES study group.
dc.date.accessioned2021-02-08T09:32:14Z
dc.date.available2021-02-08T09:32:14Z
dc.date.issued2022
dc.identifier.citationThe Journal of Infectious Diseases. 2022; 225(9):1521-1532.[Epub 2020 Dec 15]en_US
dc.identifier.issn0022-1899 (Print)
dc.identifier.issn1537-6613 (Electronic)
dc.identifier.issn0022-1899 (Linking)
dc.identifier.urihttp://repository.kln.ac.lk/handle/123456789/21935
dc.descriptionIndexed in MEDLINEen_US
dc.description.abstractBACKGROUND: Takeda's dengue vaccine is under evaluation in an ongoing Phase 3 efficacy study; we present an update after 2 years. METHODS: 20,099 children (4-16 years old) were randomized to receive two doses of TAK-003 or placebo three months apart and are under long-term febrile surveillance to detect dengue by serotype-specific RT-PCR. (NCT02747927). RESULTS: Cumulative efficacy against dengue over ~27 months since first dose was 72.7% (95% CI: 67.1 - 77.3), which included efficacy of 67.0% (95% CI: 53.6 - 76.5) in dengue-naïve and 89.2% (82.4 - 93.3) against hospitalized dengue. In the second year after vaccination, a decline in efficacy was observed [56.2% (42.3 - 66.8)] with the largest decline in 4 - 5 year-old children [24.5% (-34.2 - 57.5)]; efficacy was 60.6% (43.8 - 72.4) in 6 - 11 year and 71.2% (41.0 - 85.9) in 12 - 16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to the efficacy differences in year by year analysis. No related serious adverse events occurred during the second year. CONCLUSION: 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. KEYWORDS: Dengue; TAK-003; efficacy; immunogenicity; persistence; safety; vaccine.en_US
dc.language.isoen_USen_US
dc.publisherUniversity of Chicago Pressen_US
dc.subjectdengueen_US
dc.titleEfficacy of a dengue vaccine candidate (TAK-003) in healthy children and adolescents two years after vaccinationen_US
dc.typeArticleen_US
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