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N Engl J Med. 2015 Jan 8;372(2):113-23. doi: 10.1056/NEJMoa1411037. Epub 2014 Nov 3.

Efficacy of a tetravalent dengue vaccine in children in Latin America.

Collaborators (133)

Jackson N, Skipetrova A, Sellier-Sandrin F, Lang J, Canouet V, Urcuyo L, Noguera J, Garbes P, Papa T, de Lima FH, Soares AQ, Milan EP, Alves Mdo M, Nascimento MF, Camara LM, de Sadovsky AD, Rodrigues PM, Giuberti C, Paniago AM, Matos VG, Quintero J, Carrillo J, Osorio V, Pachón H, López R, Pardo E, Sierra V, Rodríguez E, Velasquez H, Hernández LM, Rojas E, Niederbacher J, Mandegari F EB, Vásquez A ML, Sabillón C AI, Damian LC, Camara IM, Martin MC, Troche JM, Tous JD, Quiñones J, Fors JM, Gallo S, Tila M, Moureau A, Talarico M, Carmona L, Ruat C, Chermette-Filippi P, Cochet N, Terle C, Ochiai L, Ojeda J, Sarti E, Orlowski S, Gomez V, Garcia F, Eriksson P, van der Vliet D, Ibagón S, González H, Mendoza S, Penido F, Shinohara E, Campos M, Cruz M, Guzmán AC, Pérez L, Guy B, Buffin B, Gailhardou S, L'Azou M, Chambonneau L, Marsh G, Dagot A, Plavosin C, Persico JS, Richetin-Guilluy A, Buenzli M, Gilles S, Rotario C, Morgan L, Ghanzafari N, Padieu-Sequeira A, Soto C, Manni M, Turine M, Tognini JR, da Silva Filho JQ, Molino LP, Andrade MF, Cheibub AC, Figueiredo PF, David AP, Souza CS, Jabur AP, Gonçalves AV, Modesto AC, de Aguiar PP, Oliveira AL, Figueiredo J, Nuñez P LA, Rivera JA, Giraldo LM, Monsalve MP, Gutiérrez LA, Alvarez DR, Henao EA, Otero FD, Canahuati LE, Castillo DE, Ordóñez SA, Ferrari ML, García JR, Villagomez M S, Mendez G JF, Gomez S, Villareal A, Gotos J, Zayas E, Cortés R, Aguayo R, Martínez M, von Sonnenburg F, Aranda CM, Marques SR, Cordero J, Smith P, Kalayanarooj S, Hock QS, Jokinen J, Hien TT, Istúriz R.

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The authors' affiliations are listed in the Appendix.

Abstract

BACKGROUND:

In light of the increasing rate of dengue infections throughout the world despite vector-control measures, several dengue vaccine candidates are in development.

METHODS:

In a phase 3 efficacy trial of a tetravalent dengue vaccine in five Latin American countries where dengue is endemic, we randomly assigned healthy children between the ages of 9 and 16 years in a 2:1 ratio to receive three injections of recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) or placebo at months 0, 6, and 12 under blinded conditions. The children were then followed for 25 months. The primary outcome was vaccine efficacy against symptomatic, virologically confirmed dengue (VCD), regardless of disease severity or serotype, occurring more than 28 days after the third injection.

RESULTS:

A total of 20,869 healthy children received either vaccine or placebo. At baseline, 79.4% of an immunogenicity subgroup of 1944 children had seropositive status for one or more dengue serotypes. In the per-protocol population, there were 176 VCD cases (with 11,793 person-years at risk) in the vaccine group and 221 VCD cases (with 5809 person-years at risk) in the control group, for a vaccine efficacy of 60.8% (95% confidence interval [CI], 52.0 to 68.0). In the intention-to-treat population (those who received at least one injection), vaccine efficacy was 64.7% (95% CI, 58.7 to 69.8). Serotype-specific vaccine efficacy was 50.3% for serotype 1, 42.3% for serotype 2, 74.0% for serotype 3, and 77.7% for serotype 4. Among the severe VCD cases, 1 of 12 was in the vaccine group, for an intention-to-treat vaccine efficacy of 95.5%. Vaccine efficacy against hospitalization for dengue was 80.3%. The safety profile for the CYD-TDV vaccine was similar to that for placebo, with no marked difference in rates of adverse events.

CONCLUSIONS:

The CYD-TDV dengue vaccine was efficacious against VCD and severe VCD and led to fewer hospitalizations for VCD in five Latin American countries where dengue is endemic. (Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01374516.).

PMID:
25365753
DOI:
10.1056/NEJMoa1411037
[Indexed for MEDLINE]
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