Publication: Efficacy of a tetravalent dengue vaccine in healthy children and adolescents
Issued Date
2019-11-21
Resource Type
ISSN
15334406
00284793
00284793
Other identifier(s)
2-s2.0-85075733280
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
New England Journal of Medicine. Vol.381, No.21 (2019), 2009-2019
Suggested Citation
Shibadas Biswal, Humberto Reynales, Xavier Saez Llorens, Pio Lopez, Charissa Borja Tabora, Pope Kosalaraksa, Chukiat Sirivichayakul, Veerachai Watanaveeradej, Luis Rivera, Felix Espinoza, Lak Kumar Fernando, Reynaldo Dietze, Kleber Luz, Rivaldo Venancio Da Cunha, Jose Jimeno, Eduardo Lopez Medina, Astrid Borkowski, Manja Brose, Martina Rauscher, Inge LeFevre, Svetlana Bizjajeva, Lulu Bravo, Derek Wallace Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. New England Journal of Medicine. Vol.381, No.21 (2019), 2009-2019. doi:10.1056/NEJMoa1903869 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51303
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Efficacy of a tetravalent dengue vaccine in healthy children and adolescents
Author(s)
Shibadas Biswal
Humberto Reynales
Xavier Saez Llorens
Pio Lopez
Charissa Borja Tabora
Pope Kosalaraksa
Chukiat Sirivichayakul
Veerachai Watanaveeradej
Luis Rivera
Felix Espinoza
Lak Kumar Fernando
Reynaldo Dietze
Kleber Luz
Rivaldo Venancio Da Cunha
Jose Jimeno
Eduardo Lopez Medina
Astrid Borkowski
Manja Brose
Martina Rauscher
Inge LeFevre
Svetlana Bizjajeva
Lulu Bravo
Derek Wallace
Humberto Reynales
Xavier Saez Llorens
Pio Lopez
Charissa Borja Tabora
Pope Kosalaraksa
Chukiat Sirivichayakul
Veerachai Watanaveeradej
Luis Rivera
Felix Espinoza
Lak Kumar Fernando
Reynaldo Dietze
Kleber Luz
Rivaldo Venancio Da Cunha
Jose Jimeno
Eduardo Lopez Medina
Astrid Borkowski
Manja Brose
Martina Rauscher
Inge LeFevre
Svetlana Bizjajeva
Lulu Bravo
Derek Wallace
Other Contributor(s)
Centro Médico Imbanaco
Takeda Pharmaceuticals International AG
University of the Philippines Manila
Gokila
Federal University of Espirito Santo
Universidade Federal do Rio Grande do Norte
Khon Kaen University
Mahidol University
Universidade Federal de Mato Grosso do Sul
Negombo General Hospital
Takeda Vaccines
Takeda Vaccines
Centro de Atención e Investigación Médica (CAIMED)
Hospital Maternidad Nuestra Señora de la Altagracia
National Autonomous University of Nicaragua
Takeda Pharmaceuticals International AG
University of the Philippines Manila
Gokila
Federal University of Espirito Santo
Universidade Federal do Rio Grande do Norte
Khon Kaen University
Mahidol University
Universidade Federal de Mato Grosso do Sul
Negombo General Hospital
Takeda Vaccines
Takeda Vaccines
Centro de Atención e Investigación Médica (CAIMED)
Hospital Maternidad Nuestra Señora de la Altagracia
National Autonomous University of Nicaragua
Abstract
© 2019 Massachusetts Medical Society. BACKGROUND Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019. METHODS We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotypespecific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype. RESULTS Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 personyears] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the perprotocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively). CONCLUSIONS TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic.