Efficacy of a tetravalent dengue vaccine in children in Latin America

New England Journal of Medicine

Volumn 372, Issue 2, 2015, Pages 113-123

  Villar, Luis ^a   Dayan, Gustavo Horacio ^e   Arredondo García, José Luis ^f   Rivera, Doris Maribel ^h   Cunha, Rivaldo ⁱ   Deseda, Carmen ⁿ   Reynales, Humberto ^b   Costa, Maria Selma ^j   Morales Ramírez, Javier Osvaldo ^o   Carrasquilla, Gabriel ^c   Rey, Luis Carlos ^k   Dietze, Reynaldo ^l   Luz, Kleber ^m   Rivas, Enrique ^g   Montoya, Maria Consuelo Miranda ^d   Supelano, Margarita Cortés ^d   Zambrano, Betzana ^p   Langevin, Edith ^e   Boaz, Mark ^e   Tornieporth, Nadia ^e   Saville, Melanie ^e   Noriega, Fernando ^e   more..

^a UNIVERSIDAD INDUSTRIAL DE SANTANDER   (Colombia)

^b Centro de Atención e Investigación Médica   (Colombia)

^c HOSPITAL UNIVERSITARIO FUNDACIÓN SANTA FE DE BOGOTÁ   (Colombia)

^d Sanofi Pasteur   (Colombia)

^e SANOFI PASTEUR   (France)

^f INSTITUTO NACIONAL DE PEDIATRÍA   (Mexico)

^g Sanofi Pasteur   (Mexico)

^h Clinical Research Department   (Honduras)

ⁱ FEDERAL UNIVERSITY OF MATO GROSSO DO SUL   (Brazil)

^j FEDERAL UNIVERSITY OF GOIÁS   (Brazil)

^k FEDERAL UNIVERSITY OF CEARÁ   (Brazil)

^l FEDERAL UNIVERSITY OF ESPÍRITO SANTO   (Brazil)

^m FEDERAL UNIVERSITY OF RIO GRANDE DO NORTE   (Brazil)

ⁿ Caribbean Travel Medicine Clinic   (Puerto Rico)

^o Clinical Research Puerto Rico Inc   (Puerto Rico)

^p Sanofi Pasteur   (Uruguay)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DENGUE VACCINE; PLACEBO; LIVE VACCINE; VIRUS ANTIBODY;

ACCIDENTAL INJURY; ADOLESCENT; ALLERGIC ASTHMA; ALLERGIC URTICARIA; ANTIBODY TITER; ARTICLE; CHILD; CHILD HEALTH; CONTROLLED STUDY; DENGUE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; ENDEMIC DISEASE; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFECTION; INJURY; INTENTION TO TREAT ANALYSIS; KIDNEY FAILURE; MALE; MULTICENTER STUDY; NORMAL HUMAN; PHASE 3 CLINICAL TRIAL; POLYNEUROPATHY; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SEIZURE; SEROTYPE; SINGLE BLIND PROCEDURE; SOUTH AND CENTRAL AMERICA; SYSTEMIC VASCULITIS; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VIRUS MENINGITIS; BLOOD; CLINICAL TRIAL; DENGUE VIRUS; ENDEMIC DISEASES; GENETICS; HOSPITALIZATION; IMMUNOLOGY; ISOLATION AND PURIFICATION; SEVERITY OF ILLNESS INDEX; VIROLOGY;

ADOLESCENT; ANTIBODIES, VIRAL; CHILD; DENGUE; DENGUE VACCINES; DENGUE VIRUS; ENDEMIC DISEASES; FEMALE; HOSPITALIZATION; HUMANS; INTENTION TO TREAT ANALYSIS; LATIN AMERICA; MALE; SEROGROUP; SEVERITY OF ILLNESS INDEX; SINGLE-BLIND METHOD; TREATMENT OUTCOME; VACCINES, ATTENUATED;

EID: 84920585186     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1411037     Document Type: Article

References (31)

1. Brathwaite Dick O, San Martín JL, Montoya RH, del Diego J, Zambrano B, Dayan GH. The history of dengue outbreaks in the Americas. Am J Trop Med Hyg 2012;87:584-93.
2. San Martín JL, Brathwaite O, Zambrano B, et al. The epidemiology of dengue in the Americas over the last three decades: a worrisome reality. Am J Trop Med Hyg 2010;82:128-35.
3. Zambrano B, San Martin JL. Epidemiology of dengue in Latin America. J Pediatric Infect Dis Soc 2014;3:181-2.
4. Guzman A, Istúriz RE. Update on the global spread of dengue. Int J Antimicrob Agents 2010;36:Suppl 1:S40-S42.
5. Guzman MG, Halstead SB, Artsob H, et al. Dengue: a continuing global threat. Nat Rev Microbiol 2010;8:Suppl:S7-S16.
6. Lam SK. Challenges in reducing dengue burden; diagnostics, control measures and vaccines. Expert Rev Vaccines 2013;12:995-1010.
7. McArthur MA, Sztein MB, Edelman R. Dengue vaccines: recent developments, ongoing challenges and current candidates. Expert Rev Vaccines 2013;12:933-53.
8. Capeding MR, Tran NH, Hadinegoro SR, et al. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet 2014;384:1358-65.
9. Dayan GH, Thakur M, Boaz M, Johnson C. Safety and immunogenicity of three tetravalent dengue vaccine formulations in healthy adults in the USA. Vaccine 2013;31:5047-54.
10. Lanata CF, Andrade T, Gil AI, et al. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine 2012;30:5935-41.
11. Leo YS, Wilder-Smith A, Archuleta S, et al. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2-45 y: Phase II randomized controlled trial in Singapore. Hum Vaccin Immunother 2012; 8:1259-71.
12. Sabchareon A, Wallace D, Sirivichayakul C, et al. Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Lancet 2012;380:1559-67.
13. Tran NH, Luong CQ, Vu TQH, et al. Safety and immunogenicity of recombinant, live attenuated tetravalent dengue vaccine (CYD-TDV) in healthy Vietnamese adults and children. J Vaccines Vaccin 2012;3:1-7.
14. Villar LA, Rivera-Medina DM, Arredondo-García JL, et al. Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America. Pediatr Infect Dis J 2013; 32:1102-9.
15. Dayan GH, Garbes P, Noriega F, et al. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg 2013;89:1058-65.
16. Guy B, Barrere B, Malinowski C, Saville M, Teyssou R, Lang J. From research to phase III: preclinical, industrial and clinical development of the Sanofi Pasteur tetravalent dengue vaccine. Vaccine 2011;29:7229-41.
17. Timiryasova TM, Bonaparte MI, Luo P, Zedar R, Hu BT, Hildreth SW. Optimization and validation of a plaque reduction neutralization test for the detection of neutralizing antibodies to four serotypes of dengue virus used in support of dengue vaccine development. Am J Trop Med Hyg 2013;88:962-70.
18. Boaz M, Janosczyk H, Garg S, et al. Virological confirmation of suspected dengue in a Phase 2 Latin American vaccine trial: implications for vaccine efficacy evaluation. Trials Vaccinol 2014;3:127-33.
19. Hombach J. Guidelines for clinical trials of dengue vaccine in endemic areas. J Clin Virol 2009;46:Suppl 2:S7-S9.
20. Dengue haemorrhagic fever: diagnosis, treatment, prevention and control. 2nd ed. Geneva: World Health Organization, 1997 (http://www.who.int/csr/resources/publications/dengue/Denguepublication/en/).
21. Breslow NE, Day NE. Statistical methods in cancer research. Vol. II. The design and analysis of cohort studies. Lyon, France: International Agency for Research on Cancer, 1987:94-5.
22. Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983;249:1743-5.
23. Rothman AL. Immunity to dengue virus: a tale of original antigenic sin and tropical cytokine storms. Nat Rev Immunol 2011;11:532-43.
24. Cafferata ML, Bardach A, Rey-Ares L, et al. Dengue epidemiology and burden of disease in Latin America and the Caribbean: a systematic review of the literature and meta-analysis. Value Health Reg Iss 2013;2:347-56.
25. Shepard DS, Coudeville L, Halasa YA, Zambrano B, Dayan GH. Economic impact of dengue illness in the Americas. Am J Trop Med Hyg 2011;84:200-7.
26. Suaya JA, Shepard DS, Siqueira JB, et al. Cost of dengue cases in eight countries in the Americas and Asia: a prospective study. Am J Trop Med Hyg 2009;80:846-55.
27. Vieira Machado AA, Estevan AO, Sales A, Brabes KC, Croda J, Negr.o FJ. Direct costs of dengue hospitalization in Brazil: public and private health care systems and use of WHO guidelines. PLoS Negl Trop Dis 2014;8(9):e3104.
28. Van der Vliet D, Skipetrova A, Dayan G, et al. Safety of the CYD dengue vaccine: insights from an integrated analysis of 5,344 individuals vaccinated in nine clinical trials. In: Proceedings of the American Society of Tropical Medicine and Hygiene 62nd Annual Meeting, Washington, DC, November 13-17, 2013.
29. da Costa VG, Marques-Silva AC, Floriano VG, Moreli ML. Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials. Vaccine 2014;32:4885-92.
30. Poo J, Galan F, Forrat R, Zambrano B, Lang J, Dayan GH. Live-attenuated tetravalent dengue vaccine in dengue-naive children, adolescents, and adults in Mexico City: randomized controlled phase 1 trial of safety and immunogenicity. Pediatr Infect Dis J 2010 October 29 (Epub ahead of print).
31. Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis 2012;54:1615-7.