Tetravalent Dengue Vaccine: A Review in the Prevention of Dengue Disease

Drugs

Volumn 76, Issue 13, 2016, Pages 1301-1312

  Scott, Lesley J ^a  

^a SPRINGER   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

DENGUE VACCINE; TETRAVALENT DENGUE VACCINE; UNCLASSIFIED DRUG; CYD-TDV VACCINE; LIVE VACCINE;

ADOLESCENT; ARTICLE; ASTHENIA; CHILD; CLINICAL TRIAL (TOPIC); DENGUE; DENGUE VIRUS 1; DENGUE VIRUS 2; DENGUE VIRUS 3; DENGUE VIRUS 4; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG SAFETY; DRUG TOLERABILITY; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; INFECTION PREVENTION; INJECTION SITE REACTION; MALAISE; MYALGIA; NONHUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); ADULT; ASIA; DENGUE VIRUS; ECONOMICS; FEMALE; IMMUNOLOGY; MALE; MIDDLE AGED; PREGNANCY; PRESCHOOL CHILD; SOUTH AND CENTRAL AMERICA; YOUNG ADULT;

ADOLESCENT; ADULT; ASIA; CHILD; CHILD, PRESCHOOL; DENGUE; DENGUE VACCINES; DENGUE VIRUS; FEMALE; HUMANS; LATIN AMERICA; MALE; MIDDLE AGED; PREGNANCY; VACCINES, ATTENUATED; YOUNG ADULT;

EID: 84981164499     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-016-0626-8     Document Type: Article

References (67)

1. World Health Organization. Global strategy for dengue prevention and control. 2012. http://www.who.int/. Accessed 1 Apr 2016.
2. World Health Organization. Dengue and severe dengue: fact sheet. 2016. http://www.who.int/. Accessed 1 Apr 2016.
3. Shepard DS, Undurranga EA, Halasa YA, et al. The global economic burden of dengue: a systematic analysis. Lancet Infect Dis. 2016. doi:10.1016/S1473-3099(16)00146-8.
4. Nedjadi T, El-Kafrawy S, Sohrab SS, et al. Tackling dengue fever: current status and challenges. Virol J. 2015;12:212.
5. Sarti E, L’Azou M, Mercado M, et al. A comparative study on active and passive epidemiological surveillance for dengue in five countries of Latin America. Int J Infect Dis. 2016;44:44–9.
6. Dantes HG, Farfan-Ale JA, Sarti E. Epidemiological trends of dengue disease in Mexico (2000–2011): a systematic literature search and analysis. PLoS Negl Trop Dis. 2014;8(11):e3158.
7. Bravo L, Roque VG, Brett J, et al. Epidemiology of dengue disease in the Philippines (2000-2011): a systematic literature review. PLoS Negl Trop Dis. 2014;8(11):e3027.
8. Mohd-Zaki AH, Brett J, Ismail E, et al. Epidemiology of dengue disease in Malaysia (2000–2012): a systematic literature review. PLoS Negl Trop Dis. 2014;8(11):e3159.
9. L’Azou M, Taurel AF, Flamand C, et al. Recent epidemiological trends of dengue in the French territories of the Americas (2000–2012): a systematic literature review. PLoS Negl Trop Dis. 2014;8(11):e3235.
10. Limkittikul K, Brett J, L’Azou M. Epidemiological trends of dengue disease in Thailand (2000–2011): a systematic literature review. PLoS Negl Trop Dis. 2014;8(11):e3241.
11. Teixeira MG, Siqueira JB Jr, Ferreira GL, et al. Epidemiological trends of dengue disease in Brazil (2000–2010): a systematic literature search and analysis. PLoS Negl Trop Dis. 2013;7(12):e2520.
12. Villar LA, Rojas DP, Besada-Lombana S, et al. Epidemiological trends of dengue disease in Colombia (2000–2011): a systematic review. PLoS Negl Trop Dis. 2015. doi:10.1371/journal.pntd.0003499.
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(7):162.
14. Bhatt S, Gething PW, Brady OJ, et al. The global distribution and burden of dengue. Nature. 2013;496(7446):504–7.
15. Screaton G, Mongkolsapaya J, Yacoub Y, et al. New insights into the immunopathology and control of dengue virus infection. Nat Rev Immunol. 2015;15:745–59.
16. Peeling RW, Artsob H, Pelegrino JL, et al. Evaluation of diagnostic tests: dengue. Nat Rev Microbiol. 2010;8(12 Suppl):S30–8.
17. L’Azou M, Moureau A, Sarti E, et al. Symptomatic dengue in children in 10 Asian and Latin American countries. N Engl J Med. 2016;374(12):1155–66.
18. Guy B, Lang J, Saville M, et al. Vaccination against dengue: challenges and current developments. Annu Rev Med. 2016;67:387–404.
19. Guy B, Briand O, Lang J, et al. Development of the Sanofi Pastuer tetravalent dengue vaccine: one more step forward. Vaccine. 2015;33:7100–11.
20. Parthiban N, Sivapalan N. Systematic review on immunogenicity and safety of CYD-TDV candidate vaccine. Am Med Stud Res J. 2015;1(2):115–25.
21. ® is a historic milestone paving the way to significantly impact dengue burden in endemic countries. 2015. http://www.sanofipastuer.com/. Accessed 1 Jan 2016.
22. Sanofi Pasteur. Global introduction of the first dengue vaccine gains further momentum with this third approval in a row in an endemic country. 2015. http://www.sanofipasteur.com/. Accessed 1 Apr 2016.
23. Pasteur Sanofi. Dengvaxia MD, powder and solvent for suspension for injection: Philippines summary of product characteristics. Lyon: Sanofi Pasteur; 2015.
24. Guy B, Barrere B, Malinowski C, et al. From research to phase III: preclinical, industrial and clinical development of the Sanofi Pasteur tetravalent dengue vaccine. Vaccine. 2011;29(42):7229–41.
25. Dubayle J, Vialle S, Schneider D, et al. Site-specific characterization of envelope protein N-glycosylation on Sanofi Pasteur’s tetravalent CYD dengue vaccine. Vaccine. 2015;33(11):1360–8.
26. Villar LA, Rivera-Medina DM, Arredondo-Garcia 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(10):1102–9.
27. Leo YS, Wilder-Smith A, Archuleta S, et al. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2–45 years: phase II randomized controlled trial in Singapore. Human Vaccin Immunother. 2012;8(9):1259–71.
28. Dubey AP, Agarkhedkar S, Chhatwal J, et al. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: a randomized, observer-blind, placebo-controlled phase II trial. Human Vaccin Immunother. 2016;12(2):512–8.
29. Hss A-S, Koh M-T, Tan KK, et al. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2–11 years in Malaysia: a randomized, placebo-controlled, phase III study. Vaccine. 2013;31(49):5814–21.
30. 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(9853):1559–67.
31. 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(9951):1358–65.
32. Villar L, Dayan GH, Arredondo-Garcia JL, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015;372(2):113–23.
33. 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(6):1058–65.
34. 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(41):5935–41.
35. Capeding RZ, Luna IA, Bomasang E, et al. Live-attenuated, tetravalent dengue vaccine in children, adolescents and adults in a dengue endemic country: randomized controlled phase I trial in the Philippines. Vaccine. 2011;29(22):3863–72.
36. Morrison D, Legg TJ, Billings CW, et al. A novel tetravalent dengue vaccine is well tolerated and immunogenic against all 4 serotypes in flavivirus-naive adults. J Infect Dis. 2010;201(3):370–7.
37. Poo J, Galan F, Forrat R, et al. 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. 2011;30(1):e9–17.
38. Torresi J, Heron LG, Qiao M, et al. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Vaccine. 2015;33(39):5127–34.
39. Dorigatti I, Aguas R, Donnelly CA, et al. Modelling the immunological response to a tetravalent dengue vaccine from multiple phase-2 trials in Latin America and South East Asia. Vaccine. 2015;33(31):3746–51.
40. Menezes J, Frago C, Laot T, et al. Integrated analysis of immunogenicity data from 11 dengue vaccine trials across 14 countries [abstract]. Int J Infect Dis. 2016;45:442.
41. Qiao M, Shaw D, Forrat R, et al. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011;85(4):724–31.
42. Capeding MR, Laot TM, Boaz M, et al. Immunogenicity and safety of a tetravalent dengue vaccine during a five-year follow-up period. Trials Vaccin. 2015;4:19–23.
43. Harenberg A, Begue S, Mamessier A, et al. Persistence of Th1/Tc1 responses one year after tetravalent dengue vaccination in adults and adolescents in Singapore. Human Vaccin Immunother. 2013;9(11):2317–25.
44. Guy B, Nougarede N, Begue S, et al. Cell-mediated immunity induced by chimeric tetravalent dengue vaccine in naive or flavivirus-primed subjects. Vaccine. 2008;26(45):5712–21.
45. Guy B. Immunogenicity of sanofi pasteur tetravalent dengue vaccine. J Clin Virol. 2009;46(Suppl 2):S16–9.
46. Guy B, Guirakhoo F, Barban V, et al. Preclinical and clinical development of YFV 17D-based chimeric vaccines against dengue, West Nile and Japanese encephalitis viruses. Vaccine. 2010;28(3):632–49.
47. Hadinegoro SR, Arredondo-Garcia JL, Capeding MR, et al. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med. 2015;373(13):1195–206.
48. 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(1):127–33.
49. Olivera-Botello G, Coudeville L, Fanouillere K, et al. Tetravalent dengue vaccine reduces symptomatic and asymptomatic dengue infections in healthy children and adolescents aged 2–16 years in Asia and Latin America. J Infect Dis. 2016. doi:10.1093/infdis/jiw297.
50. Gailhardou S, Skipetrova A, Dayan G, et al. Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials. PLoS Negl Trop Dis. 2016. doi:10.1371/journal.ptnd.0004821.
51. ® approved in El Salvador. 2016. http://www.sanofipasteur.com/. Accessed 21 Apr 2016.
52. WHO Strategic Advisory Group of Experts. Weekly epidemiological record: dengue vaccine. Wkly Epidemiol Rec. 2016;91(21):282–4.
53. Achee NL, Gould F, Perkins TA, et al. A critical assessment of vector control for dengue prevention. PLoS Negl Trop Dis. 2015;9(5):e0003655.
54. Scott TW, Morison AC. Vector dynamics and transmission of dengue virus: implications for dengue surveillance and prevention strategies. Vector dynamics and prevention strategies. Curr Top Microbiol Immunol. 2010;338:115–28.
55. Guy B, Jackson N. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection. Nat Rev Microbiol. 2016;14:45–54.
56. Sanofi Pasteur. Use of Sanofi Pasteur’s dengue vaccine in endemic countries. 2016. http://www.sanofipasteur.com/. Accessed 14 Apr 2016.
57. Lin L, Thomas SJ. Current dengue vaccine status. Curr Trop Med Rep. 2014;1:6–12.
58. Rodriguez-Barraquer I, Mier-y-Teran-Romero L, Schwartz IB, et al. Potential opportunities and perils of imperfect dengue vaccines. Vaccine. 2014;32(4):514–20.
59. Tozan Y. Current issues in the economics of vaccination against dengue. Expert Rev Vaccines. 2016. doi:10.1586/14760584.2016.1129278.
60. Wilder-Smith A. Dengue vaccines: dawning at last? Lancet. 2014;384(9951):1327–9.
61. Orellano PW, Reynoso JI, Stahl H-C. Cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission. Vaccine. 2016;34(5):616–21.
62. Lam H, Ku GM, Wu D, et al. Cost-effectiveness analysis of dengue vaccination in the Philippines [abstract]. Int J Infect Dis. 2016;45:421.
63. Yeo HY, Shafie AA, Coudeville L, et al. Potential health and economic impact of introducing a dengue vaccine in Malaysia: assessment using dynamic transmission modelling [abstract no: PIN39]. In: IPSOR 18th Annual European Congress. 2015.
64. Yeo HY, Shafie AA, Coudeville L, et al. Exploring the cost-effective threshold price of dengue vaccination programs in Malaysia: a value-based pricing assessment [abstract no. PIN38] In: IPSOR 21st Annual International Meeting. 2016.
65. Castro R, Rueda-Gallardo JA, Avella MF, et al. Cost-effectiveness of dengue vaccine 2014 [abstract]. In: IPSOR 5th Latin America Conference. 2015.
66. Coudeville L, Baurin N, Shepard D, et al. Potential impact and economic value of dengue vaccination in 10 endemic countries [abstract no. 41.195]. In: ICID. 2016.
67. Gessner BD, Wilder-Smith A. Estimating the public health importance of the CYD-tetravalent dengue vaccine: vaccine preventable disease incidence and numbers needed to vaccinate. Vaccine. 2016;34:2397–401.