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Embargo date
2025
Sustainable Development Goals
03 Saúde e Bem-EstarCollections
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EFFICACY AND SAFETY OF A TETRAVALENT DENGUE VACCINE (TAK-003) IN CHILDREN WITH PRIOR JAPANESE ENCEPHALITIS OR YELLOW FEVER VACCINATION
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Abstract
Background. We explored the impact of prior yellow fever (YF) or Japanese encephalitis (JE) vaccination on the efficacy of Takeda’s dengue vaccine candidate, TAK-003. Methods. Children 4–16 years of age were randomized 2:1 to receive TAK-003 or placebo and were under active febrile surveillance. Symptomatic dengue was confirmed by serotype-specific reverse-transcription polymerase chain reaction. YF and JE vaccination history was recorded. Results. Of the 20 071 children who received TAK-003 or placebo, 21.1% had a YF and 23.9% had a JE vaccination history at randomization. Fifty-seven months after vaccination, vaccine efficacy (95% confidence interval) was 55.7% (39.7%–67.5%) in those with YF vaccination, 77.8% (70.8%–83.1%) for JE vaccination, and 53.5% (45.4%–60.4%) for no prior YF/JE vaccination. Regional differences in serotype distribution confound these results. The apparent higher vaccine efficacy in the JE vaccination subgroup could be largely explained by serotype-specific efficacy of TAK-003. Within 28 days of any vaccination, the proportions of participants with serious adverse events in the YF/JE prior vaccination population were comparable between the TAK-003 and placebo groups. Conclusions. The available data do not suggest a clinically relevant impact of prior JE or YF vaccination on TAK-003 performance.Overall, TAK-003 was well-tolerated and efficacious in different epidemiological settings.
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