Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination
4
Issued Date
2024-12-15
Resource Type
ISSN
00221899
eISSN
15376613
Scopus ID
2-s2.0-85203402304
Pubmed ID
38682569
Journal Title
Journal of Infectious Diseases
Volume
230
Issue
6
Start Page
e1214
End Page
e1225
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Infectious Diseases Vol.230 No.6 (2024) , e1214-e1225
Suggested Citation
Sirivichayakul C., Biswal S., Saez-Llorens X., López-Medina E., Borja-Tabora C., Bravo L., Kosalaraksa P., Alera M.T., Reynales H., Rivera L., Watanaveeradej V., Yu D., Espinoza F., Dietze R., Fernando L.K., Wickramasinghe V.P., Moreira E.D., Fernando A.D., Gunasekera D., Luz K., Venâncio Da Cunha R., Oliveira A.L., Rauscher M., Fan H., Borkowski A., Escudero I., Tuboi S., Lloyd E., Tricou V., Folschweiller N., Lefevre I., Vargas L.M., Wallace D., Fernando A., Borja-Tabora C., Sirivichayakul C., Yu D., Gunasekera D., López-Medina E., Rodriguez-Arenales E.J., Moreira E.D., Espinoza F., Velásquez H., Reynales H., Luz K., Jimeno J., Fernando L.K., Bravo L., Vargas L.M., Rivera L., Alera M.T., Manacharoen O., Lopez P., Kosalaraksa P., Pujitha Wickramasinghe V., Dietze R., Da Cunha R.V., Watanaveeradej V., Saez-Llorens X., Brose M., Biswal S., Hutagalung Y., Tuboi S. Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination. Journal of Infectious Diseases Vol.230 No.6 (2024) , e1214-e1225. e1225. doi:10.1093/infdis/jiae222 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/102535
Title
Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination
Author(s)
Sirivichayakul C.
Biswal S.
Saez-Llorens X.
López-Medina E.
Borja-Tabora C.
Bravo L.
Kosalaraksa P.
Alera M.T.
Reynales H.
Rivera L.
Watanaveeradej V.
Yu D.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe V.P.
Moreira E.D.
Fernando A.D.
Gunasekera D.
Luz K.
Venâncio Da Cunha R.
Oliveira A.L.
Rauscher M.
Fan H.
Borkowski A.
Escudero I.
Tuboi S.
Lloyd E.
Tricou V.
Folschweiller N.
Lefevre I.
Vargas L.M.
Wallace D.
Fernando A.
Borja-Tabora C.
Sirivichayakul C.
Yu D.
Gunasekera D.
López-Medina E.
Rodriguez-Arenales E.J.
Moreira E.D.
Espinoza F.
Velásquez H.
Reynales H.
Luz K.
Jimeno J.
Fernando L.K.
Bravo L.
Vargas L.M.
Rivera L.
Alera M.T.
Manacharoen O.
Lopez P.
Kosalaraksa P.
Pujitha Wickramasinghe V.
Dietze R.
Da Cunha R.V.
Watanaveeradej V.
Saez-Llorens X.
Brose M.
Biswal S.
Hutagalung Y.
Tuboi S.
Biswal S.
Saez-Llorens X.
López-Medina E.
Borja-Tabora C.
Bravo L.
Kosalaraksa P.
Alera M.T.
Reynales H.
Rivera L.
Watanaveeradej V.
Yu D.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe V.P.
Moreira E.D.
Fernando A.D.
Gunasekera D.
Luz K.
Venâncio Da Cunha R.
Oliveira A.L.
Rauscher M.
Fan H.
Borkowski A.
Escudero I.
Tuboi S.
Lloyd E.
Tricou V.
Folschweiller N.
Lefevre I.
Vargas L.M.
Wallace D.
Fernando A.
Borja-Tabora C.
Sirivichayakul C.
Yu D.
Gunasekera D.
López-Medina E.
Rodriguez-Arenales E.J.
Moreira E.D.
Espinoza F.
Velásquez H.
Reynales H.
Luz K.
Jimeno J.
Fernando L.K.
Bravo L.
Vargas L.M.
Rivera L.
Alera M.T.
Manacharoen O.
Lopez P.
Kosalaraksa P.
Pujitha Wickramasinghe V.
Dietze R.
Da Cunha R.V.
Watanaveeradej V.
Saez-Llorens X.
Brose M.
Biswal S.
Hutagalung Y.
Tuboi S.
Author's Affiliation
National Autonomous University of Nicaragua, Leon
Faculty of Tropical Medicine, Mahidol University
Takeda Pharma AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Universidade Federal do Espírito Santo
Faculty of Medicine, Khon Kaen University
Fundacao Oswaldo Cruz
Universidade Federal do Rio Grande do Norte
Universidade Federal de Mato Grosso do Sul
Phramongkutklao College of Medicine
Clinchoice Inc
Virology
Research Institute for Tropical Medicine
Takeda Distribuidora Ltda
University of Sri Jayawardenenpura
Centro de Atención e Investigación Médica Dominicana
Negombo General Hospital
Hospital del Niño Dr. José Renán Esquivel
Centro de Atención e Investigación Médica (CAIMED)
Hospital Universitario Maternidad Nuestra Señora de la Altagracia
Faculty of Tropical Medicine, Mahidol University
Takeda Pharma AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Universidade Federal do Espírito Santo
Faculty of Medicine, Khon Kaen University
Fundacao Oswaldo Cruz
Universidade Federal do Rio Grande do Norte
Universidade Federal de Mato Grosso do Sul
Phramongkutklao College of Medicine
Clinchoice Inc
Virology
Research Institute for Tropical Medicine
Takeda Distribuidora Ltda
University of Sri Jayawardenenpura
Centro de Atención e Investigación Médica Dominicana
Negombo General Hospital
Hospital del Niño Dr. José Renán Esquivel
Centro de Atención e Investigación Médica (CAIMED)
Hospital Universitario Maternidad Nuestra Señora de la Altagracia
Corresponding Author(s)
Other Contributor(s)
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.