Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination
Publication Date
12-15-2024
Document Type
Article
Publication Title
Journal of Infectious Diseases
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. Clinical Trials Registration. NCT02747927.
First Page
e1214
Last Page
e1225
APA Citation
Sirivichayakul, C.,
Sirivichayakul, C.,
Biswal, S.,
Biswal, S.,
Saez-Llorens, X.,
Saez-Llorens, X.,
López-Medina, E.,
López-Medina, E.,
Borja-Tabora, C.,
Borja-Tabora, C.,
Bravo, L.,
Bravo, L.,
Kosalaraksa, P.,
Kosalaraksa, P.,
Alera, M.,
Alera, M.,
Reynales, H.,
Reynales, H.,
Rivera, L.,
Rivera, L.,
Watanaveeradej, V.,
Watanaveeradej, V.,
Yu, D.,
Yu, D.,
Espinoza, F.,
Espinoza, F.,
Dietze, R.,
Dietze, R.,
Fernando, L.,
Fernando, L.,
Wickramasinghe, V.,
Moreira, E.,
&
Moreira, E.
(12-15-2024).
Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination.
Faculty Research and Scholarly Works.
DOI:10.1093/infdis/jiae222