Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination
Issued Date
2022-05-01
Resource Type
ISSN
00221899
eISSN
15376613
Scopus ID
2-s2.0-85107885449
Pubmed ID
33319249
Journal Title
Journal of Infectious Diseases
Volume
225
Issue
9
Start Page
1521
End Page
1532
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Infectious Diseases Vol.225 No.9 (2022) , 1521-1532
Suggested Citation
López-Medina E., Biswal S., Saez-Llorens X., Borja-Tabora C., Bravo L., Sirivichayakul C., Vargas L.M., Alera M.T., Velásquez H., Reynales H., Rivera L., Watanaveeradej V., Rodriguez-Arenales E.J., Yu D., Espinoza F., Dietze R., Fernando L.K., Wickramasinghe P., Duarte Moreira E., Fernando A.D., Gunasekera D., Luz K., Da Cunha R.V., Tricou V., Rauscher M., Liu M., Lefevre I., Wallace D., Kosalaraksa P., Borkowski A. Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination. Journal of Infectious Diseases Vol.225 No.9 (2022) , 1521-1532. 1532. doi:10.1093/infdis/jiaa761 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85948
Title
Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination
Author(s)
López-Medina E.
Biswal S.
Saez-Llorens X.
Borja-Tabora C.
Bravo L.
Sirivichayakul C.
Vargas L.M.
Alera M.T.
Velásquez H.
Reynales H.
Rivera L.
Watanaveeradej V.
Rodriguez-Arenales E.J.
Yu D.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe P.
Duarte Moreira E.
Fernando A.D.
Gunasekera D.
Luz K.
Da Cunha R.V.
Tricou V.
Rauscher M.
Liu M.
Lefevre I.
Wallace D.
Kosalaraksa P.
Borkowski A.
Biswal S.
Saez-Llorens X.
Borja-Tabora C.
Bravo L.
Sirivichayakul C.
Vargas L.M.
Alera M.T.
Velásquez H.
Reynales H.
Rivera L.
Watanaveeradej V.
Rodriguez-Arenales E.J.
Yu D.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe P.
Duarte Moreira E.
Fernando A.D.
Gunasekera D.
Luz K.
Da Cunha R.V.
Tricou V.
Rauscher M.
Liu M.
Lefevre I.
Wallace D.
Kosalaraksa P.
Borkowski A.
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Takeda Pharmaceuticals International AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
Gokila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Federal University of Espirito 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
Centro de Atención e Investigación Médica
University of Sri Jayawardenenpura
Centro de Atención e Investigación Médica Dominicana
Negombo General Hospital
Centro de Atención e Investigación Médica
Hospital del Niño Dr. José Renán Esquivel
Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit
Centro de Atención e Investigación Médica
Takeda Vaccines Inc.
Hospital Maternidad Nuestra Señora de la Altagracia
National Autonomous University of Nicaragua
Takeda Pharmaceuticals International AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
Gokila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Federal University of Espirito 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
Centro de Atención e Investigación Médica
University of Sri Jayawardenenpura
Centro de Atención e Investigación Médica Dominicana
Negombo General Hospital
Centro de Atención e Investigación Médica
Hospital del Niño Dr. José Renán Esquivel
Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit
Centro de Atención e Investigación Médica
Takeda Vaccines Inc.
Hospital Maternidad Nuestra Señora de la Altagracia
National Autonomous University of Nicaragua
Other Contributor(s)
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.