| Author | Sirivichayakul, Chukiat | |
| Author | Biswal, Shibadas | |
| Author | Saez-Llorens, Xavier | |
| Author | López-Medina, Eduardo | |
| Author | Borja-Tabora, Charissa | |
| Author | Bravo, Lulu | |
| Author | Kosalaraksa, Pope | |
| Author | Alera, Maria Theresa | |
| Author | Reynales, Humberto | |
| Author | Rivera, Luis | |
| Author | Watanaveeradej, Veerachai | |
| Author | Yu, Delia | |
| Author | Espinoza, Felix | |
| Author | Dietze, Reynaldo | |
| Author | Fernando, LakKumar | |
| Author | Wickramasinghe, V. Pujitha | |
| Author | Moreira Jr, Edson Duarte | |
| Author | Fernando, Asvini D. | |
| Author | Gunasekera, Dulanie | |
| Author | Luz, Kleber | |
| Author | Cunha, Rivaldo Venâncio da | |
| Author | Oliveira, Ana Lucia | |
| Author | Rauscher, Martina | |
| Author | Fan, Huihao | |
| Author | Borkowski, Astrid | |
| Author | Escudero, Ian | |
| Author | uboi, Suely T | |
| Author | Lloyd, Eric | |
| Author | Tricou, Vianney | |
| Author | Folschweiller, Nicolas | |
| Author | LeFevre, Inge | |
| Author | Vargas, Luis Martinez | |
| Author | Wallace, Derek | |
| Access date | 2024-08-15T21:37:36Z | |
| Available date | 2024-08-15T21:37:36Z | |
| Document date | 2024 | |
| Citation | SIRIVICHAYAKUL, Chukiat et al. Efficacy and safety of a tetravalent dengue vaccine (TAK-003) in children with prior japanese encephalitis or yellow fever vaccination. The Journal of Infectious Diseases, p. 1-12, 2024. | en_US |
| ISSN | 1537-6613 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/65392 | |
| Sponsorship | Takeda. | en_US |
| Language | eng | en_US |
| Publisher | Oxford University Press | en_US |
| Rights | restricted access | |
| Subject in Portuguese | Dengue | en_US |
| Subject in Portuguese | Encefalite japonesa | en_US |
| Subject in Portuguese | Febre amarela | en_US |
| Subject in Portuguese | Vacinação | en_US |
| Subject in Portuguese | Eficácia do TAK-003 | en_US |
| Title | Efficacy and safety of a tetravalent dengue vaccine (TAK-003) in children with prior japanese encephalitis or yellow fever vaccination | en_US |
| Type | Article | |
| DOI | 10.1093/infdis/jiae222 | |
| 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. | en_US |
| Affilliation | Department of Tropical Pediatrics. Faculty of Tropical Medicine. Mahidol University. Bangkok, Thailand. | en_US |
| Affilliation | Takeda Vaccines. Inc. Cambridge, Massachusetts, USA. | en_US |
| Affilliation | Pediatric Infectious Diseases. Hospital del Niño Dr. José Renán Esquivel. Sistema Nacional de Investigación at SENACYT. Centro de Vacunación Internacional (Cevaxin). Panama City, Panama. | en_US |
| Affilliation | Centro de Estudios en Infectologia Pediátrica. Universidad del Valle and Clínica Imbanaco Grupo Quironsalud. Cali, Colombia. | en_US |
| Affilliation | Clinical Research Division. Research Institute for Tropical Medicine. Muntinlupa, Philippines. | en_US |
| Affilliation | Pediatrics. University of the Philippines Manila. Ermita, Philippines. | en_US |
| Affilliation | Faculty of Medicine. Khon Kaen University. Khon Kaen, Thailand. | en_US |
| Affilliation | Virology, Philippines–Armed Forces Research Institute of Medical Sciences Virology Research Unit. Cebu, Philippines. | en_US |
| Affilliation | Clinical Research. Centro de Atención e Investigación Médica. Bogotá, Colombia. | en_US |
| Affilliation | Hospital Maternidad Nuestra Senora de Altagracia. Santo Domingo, Dominican Republic. | en_US |
| Affilliation | Department of Pediatrics, Phramongkutklao Hospital and Kasetsart University. Bangkok, Thailand. | en_US |
| Affilliation | Pediatrics. De La Salle Health Sciences Institute. Dasmariñas, Philippines. | en_US |
| Affilliation | National Autonomous University of Nicaragua. León, Nicaragua. | en_US |
| Affilliation | Universidade Federal do Espírito Santo. Centro de Ciências da Saúde. Núcleo de Doenças Infecciosas. Vitória, ES, Brasil. | en_US |
| Affilliation | Centre for Clinical Management of Dengue and Dengue Haemorrhagic Fever. Negombo General Hospital. Negombo, Sri Lanka. | en_US |
| Affilliation | Paediatric. University of Colombo. Colombo, Sri Lanka. | en_US |
| Affilliation | Hospital Santo Antonio. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Epidemiologia Molecular e Bioestatística. Salvador, BA, Brasil. | en_US |
| Affilliation | Faculty of Medicine. University of Kelaniya. Colombo, Sri Lanka. | en_US |
| Affilliation | Faculty of Medical Sciences. University of Sri Jayawardenenpura. Nugegoda, Sri Lanka. | en_US |
| Affilliation | Universidade Federal do Rio Grande do Norte. Instituto de Medicina Tropical. Natal, RN, Brasil. | en_US |
| Affilliation | Universidade Federal de Mato Grosso do Sul. Departamento de Doenças Infecciosas. Campo Grande, MG, Brasil. | en_US |
| Affilliation | Universidade Federal de Mato Grosso do Sul. Departamento de Doenças Infecciosas. Campo Grande, MG, Brasil. | en_US |
| Affilliation | Takeda Pharmaceuticals International AG. Zurich, Switzerland. | en_US |
| Affilliation | Clinchoice Inc. Fort Washington. Pennsylvania. | en_US |
| Affilliation | Takeda Pharmaceuticals International AG. Zurich, Switzerland. | en_US |
| Affilliation | Takeda Vaccines. Inc. Cambridge, Massachusetts, USA. | en_US |
| Affilliation | Takeda Distribuidora Ltda. São Paulo, SP, Brasil. | en_US |
| Affilliation | Takeda Vaccines. Inc. Cambridge, Massachusetts, USA. | en_US |
| Affilliation | Takeda Pharmaceuticals International AG. Zurich, Switzerland. | en_US |
| Affilliation | Takeda Pharmaceuticals International AG. Zurich, Switzerland. | en_US |
| Affilliation | Takeda Pharmaceuticals International AG. Zurich, Switzerland. | en_US |
| Affilliation | Centro de Atención e Investigación Médica. Santo Domingo, Dominican Republic. | en_US |
| Affilliation | Takeda Vaccines. Inc. Cambridge, Massachusetts, USA. | en_US |
| Subject | Dengue | en_US |
| Subject | Japanese encephalitis | en_US |
| Subject | Yellow fever | en_US |
| Subject | Vaccination | en_US |
| Subject | TAK-003 effectiveness | en_US |
| DeCS | Dengue | en_US |
| DeCS | Encefalite japonesa | en_US |
| DeCS | Febre amarela | en_US |
| DeCS | Vacinação | en_US |
| Embargo date | 2025 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
