Publication:
Efficacy and long-term safety of a dengue vaccine in regions of endemic disease

Issued Date

2015-09-24

Resource Type

Article

ISSN

15334406
00284793

DOI

10.1056/NEJMoa1506223

Other identifier(s)

2-s2.0-84942436806

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

New England Journal of Medicine. Vol.373, No.13 (2015), 1195-1206

Suggested Citation

S. R. Hadinegoro, J. L. Arredondo-García, M. R. Capeding, C. Deseda, T. Chotpitayasunondh, R. Dietze, H. I. Hj Muhammad Ismail, H. Reynales, K. Limkittikul, D. M. Rivera-Medina, H. N. Tran, A. Bouckenooghe, D. Chansinghakul, M. Cortés, K. Fanouillere, R. Forrat, C. Frago, S. Gailhardou, N. Jackson, F. Noriega, E. Plennevaux, T. A. Wartel, B. Zambrano, M. Saville Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. New England Journal of Medicine. Vol.373, No.13 (2015), 1195-1206. doi:10.1056/NEJMoa1506223 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/36320

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Title

Efficacy and long-term safety of a dengue vaccine in regions of endemic disease

Author(s)

S. R. Hadinegoro
 J. L. Arredondo-García
 M. R. Capeding
 C. Deseda
 T. Chotpitayasunondh
 R. Dietze
 H. I. Hj Muhammad Ismail
 H. Reynales
 K. Limkittikul
 D. M. Rivera-Medina
 H. N. Tran
 A. Bouckenooghe
 D. Chansinghakul
 M. Cortés
 K. Fanouillere
 R. Forrat
 C. Frago
 S. Gailhardou
 N. Jackson
 F. Noriega
 E. Plennevaux
 T. A. Wartel
 B. Zambrano
 M. Saville

Other Contributor(s)

University of Indonesia, RSUPN Dr. Cipto Mangunkusumo
 Instituto Nacional de Pediatria
 Gokila
 Caribbean Travel Medicine Clinic
 Queen Sirikit National Institute of Child Health
 Mahidol University
 Sanofi Pasteur
 Federal University of Espirito Santo
 Kuala Lumpur Hospital
 SAS-CAIMED
 Sanofi Pasteur
 Organizacion para el Desarrollo y la Investigacion Salud en Honduras (ODIS)
 Pasteur Institute in Ho Chi Minh City
 Sanofi Pasteur
 Sanofi S.A.
Sanofi Pasteur SA
 Sanofi Pasteur
 Sanofi Pasteur

Abstract

Copyright © 2015 Massachusetts Medical Society. Background: A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses. Methods: We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57. We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15. Results: Follow-up data were available for 10,165 of 10,275 participants (99%) in CYD14 and 19,898 of 20,869 participants (95%) in CYD15. Data were available for 3203 of the 4002 participants (80%) in the CYD23 trial included in CYD57. During year 3 in the CYD14, CYD15, and CYD57 trials combined, hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group. Pooled relative risks of hospitalization for dengue were 0.84 (95% confidence interval [CI], 0.56 to 1.24) among all participants, 1.58 (95% CI, 0.83 to 3.02) among those under the age of 9 years, and 0.50 (95% CI, 0.29 to 0.86) among those 9 years of age or older. During year 3, hospitalization for severe dengue, as defined by the independent data monitoring committee criteria, occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group. Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3% (95% CI, 55.7 to 64.5) for all participants, 65.6% (95% CI, 60.7 to 69.9) for those 9 years of age or older, and 44.6% (95% CI, 31.6 to 55.0) for those younger than 9 years of age. Conclusions: Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up, the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/36320

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Scopus 2011-2015