“Current Dengue Vaccine Status”

Current Tropical Medicine Reports

Volumn 1, Issue 1, 2014, Pages 6-12

  Lin, Leyi ^a   Thomas, Stephen J ^a  

^a WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

Author keywords

Dengue serotype; Dengue vaccine; DNA dengue vaccine; Merck recombinant envelope protein dengue vaccine; NIH directed mutagenesis dengue vaccine; Sanofi Pasteur chimeric yellow fever dengue vaccine; Takeda chimeric dengue vaccine; Viral tropical medicine; WRAIR GSK dengue purified inactivated vaccine

Indexed keywords

CHIMERIC YELLOW FEVER DENGUE TETRAVALENT DENGUE VACCINE; DENGUE VACCINE; ENVELOPE PROTEIN; INACTIVATED VACCINE; LIVE VACCINE; NONSTRUCTURAL PROTEIN 1; UNCLASSIFIED DRUG; VIRUS PROTEIN;

CELLULAR IMMUNITY; CLINICAL TRIAL (TOPIC); DENGUE; DENGUE VIRUS; DENGUE VIRUS 2; DRUG EFFICACY; DRUG SAFETY; HUMAN; MUTAGENESIS; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; VACCINATION; VIREMIA; VIRUS GENOME;

EID: 84937576008     PISSN: None     EISSN: 21963045     Source Type: Journal    
DOI: 10.1007/s40475-013-0006-3     Document Type: Review

References (67)

1. World Health Organization. Dengue and Severe Dengue Fact Sheet. Updated September 2013. http://www.who.int/mediacentre/factsheets/fs117/en/index.html
2. Bhatt S, Gething PW, Brady OJ, et al. The global distribution and burden of dengue. Nature. 2013;496(7446):504–7. An analysis of dengue cases, population distributions, and variation of risk suggests 390 million dengue infections per year.
3. Jansenius M, Han PV, Schlagenhauf P, et al. Acute and potentially life-threatening tropical diseases in western travelers: a GeoSentinel multicenter study. Am J Trop Med Hyg. 2013;88:397–404.
4. Gibbons RV, Streitz M, Babina T, Fried JR. Dengue and US military operations from the Spanish-American War through today. Emerg Infect Dis. 2012;18(4):623–30.
5. World Health Organization and the Special Programme for Research and Training in Tropical Diseases. Denuge: Guidelines for diagnosis, treatment, prevention, and control. 2009. Geneva. Online access: www.who.int/rpc/guidelines/9789241547871/en/
6. Morrison AC, Zielinski-Gutierrez E, Scott TW, Rosenberg R, Morrison AC, Zielinski-Gutierrez E, et al. Defining Challenges and Proposing Solutions for Control of the Virus Vector Aedes aegypti. PLOS Medicine. 2008;5(3):e68. doi:10.1371/journal.pmed.0050068.
7. Jarman RG, Holmes EC, Rodrpradit P, et al. Microevulation of Dengue virues circulating among primary school children in Kamphaeng Phet, Thailand. J Virol. 2008;82:5494–500.
8. Endy T, Nisalak A, Chunsuttiwat S, et al. Spatial and Temporal Circulation of Dengue Virus Serotypes: A prospective study of Primary School Children in Kamphaeng Phet, Thailand. Am J Epidemiol. 2002;156(1):52–9.
9. Reich N, Shrestha S, King A, et al. Interaction between serotypes of dengue highlight epidemiological impact of cross-immunity. J R Soc Interface. 2013;10(86):1–8.
10. Sabin AB. Research on dengue during World War II. Am J Trop Med Hyg. 1952;1:30–50.
11. Kochel TJ, Watts DM, Halstead SB, et al. Effect of dengue-1 antibodies on American dengue-2 viral infection and dengue haemorrhagic fever. Lancet. 2002;360:310.
12. Endy TP, Anderson KB, Nisalak A, et al. Determinants of inapparent and symptomatic dengue infection in prospective study of primary school children in Kamphaeng Phet, Thailand. PLOS Neglected Tropical Diseases. 2011;5.
13. Halstead SB, Thomas SJ. “Dengue Vaccines”. Vaccines: Plotkin, Orestein and Offit. 6th Ed. 2012: 1042-1051
14. Chanthavanich P, Luxemburger C, Sirivichayakul C, et al. Short report: immune response of dengue infection in Thai children three to eight years old after vaccination with live attenuated dengue vaccine. Am J Trop Med Hyg. 2006;75:26–8.
15. Durbin AP, Schmidt A, Elwood D, et al. Heterotypic dengue infection with live attenuated monotypic dengue virus vaccines: implications for vaccination of populations in areas where dengue is endemic. J Infect Dis. 2011;202(3):327–34.
16. McArthur M, Sztein M, Edelman R. Dengue vaccines: recent development, ongoing challenges and current candidates. Expet Rev Vaccine. 2013;12(8):933–53.
17. Thomas SJ, Endy TP. Current Issues in Dengue Vaccination. Curr Opin Infect Dis. 2013; 26: 439-434.
18. Williams KL, Zompi S, Beatty PR, Harris E. A mouse model for studying dengue virus pathogenesis and immune response. Ann N Y Acad Sci. 2009;1171:E12–23.
19. Cassetti MC, Durbin A, Harris E, et al. Report of an NIADI workshop on dengue animal models. Vaccine.
20. Endy TP, Nisalak A, Chunsuttitwat S, et al. Relationship of preexisting dengue virus (DV) neutralizing antibodies level to viremia and severity of disease in a prospective cohort study in Thailand. J Infect Dis. 2004;189(6):990–1000.
21. Thomas SJ, Nisalak A, Anderson KB, et al. Dengue plaque reduction neutralization test (PRNT) in primary secondary dengue virus infections: how alterations in assay conditions impact performance. Am J Trop Med Hyg. 2009;81:825–33.
22. Putnak JR, de la Barrera R, Burgess T, et al. Comparative evaluation of three assays for measurement of dengue virus neutralizing antibodies. Am J Trop Med Hyg. 2009;79:115–22.
23. 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.
24. Gunther VJ, Putnak R, Eckels KH, et al. A human challenge model for dengue infection reveals a possible protective role for sustained interferon gamma levels during the acute phase of illness. Vaccine. 2011;29(22):3895–904.
25. Thomas SJ, Hombach J, Barrett A. Scientific consultation on cell mediated immunity (CMI) in dengue and dengue vaccine development. Vaccine. 2009;27(3):355–68.
26. Alen MM, Schols D. Dengue virus entry as target for antiviral therapy. J Trop Med. 2012; 2012:628475.
27. Halstead SB. Identifying protective dengue vaccine: guide to mastering the empirical process. Vaccine. 2013;13:4501–7.
28. Rothman AL. Immunity to dengue virus: a tale of original antigenic sin and tropical cytokine storms. Nature reviews. Immunology. 2011;11(8):532–43.
29. Morrison D, Legg TJ, Billings CW, Forrat R, Yoksan S, Lang J. A novel tetravalent dengue vaccine is well tolerated and immunogenic against all 4 dengue serotypes in flavivirus-naïve adults. J Infect Dis. 2010;201:370–7.
30. 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 1 clinical trial in the Philippines. Vaccine. 2011;29(22):3863–72.
31. Sabchareon A, Wallace D, Sirivichayakul C, et al. Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai school children: a randomized, controlled phase 2b trial. Lancet. 2012;380:1559–67. This is an efficacy trial of the lead candidate tetravalent dengue vaccine. While the vaccine continues to be well tolerated, potential problems with protection in an endemic population were raised. The study results will impact vaccine development strategy for all candidates.
32. Whitehorn J, Simmons CP. The pathogenesis of dengue. Vaccine. 2011;29(42):7221–8.
33. Plotkin SA. Correlates of vaccine-induced immunity. Clin Infect Dis. 2008;47:401–9.
34. Guy B, Barban V, Mantel N, et al. Evaluation of interferences between dengue vaccine serotypes in a monkey model. Am J Trop Med Hyg. 2009;80:302–11.
35. Edelman R, Wasserman SS, Bodison SA, et al. Phase I trial of 16 formualations of a tetravalent live-attenuated dengue vaccine. Am J Trop Med Hyg. 2003;69:48–60.
36. Lang, J. Sanofi Pasetur CYD dengue vaccine programme update. NIAID – Dengue Vaccine Initiative. Consultation on Dengue Vaccines. 26–28 June 2013, Rockville, MD https://respond.niaid.nih.gov/conferences/DengueVaccine2013/_layouts/mobile/mbllists.aspx
37. Durbin AP, Whitehead SS, McArthur J, et al. rDENV4(delta)30, a live attenuated dengue virus type 4 vaccine candidate, is safe, immunogenic, and highly infectious in healthy adult volunteers. J Infect Dis. 2005;191(5):710–8.
38. Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monvalent DENV vaccine to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011;29:7242–50.
39. Durbin AP, Kirkpatrick BD, Pierce KK, et al. A single dose of any of four different live attenuated tetravalent dengue vaccine is safe and immunogenic in flavivirus-naïve adults: a randomized, double-blind clinical trial. J Infect Dis. 2013;207:957–65. Phase 1 results of the NIH’s vaccine candidate, which is currently in phase 2 trials.
40. Whitehead S. Safety and immunogenicity of the NIH live attenuated tetravalent dengue vaccine candidate TV003. NIAID – Dengue Vaccine Initiative. Consultation on Dengue Vaccines. 26–28 June 2013, Rockville, MD https://respond.niaid.nih.gov/conferences/DengueVaccine2013/_layouts/mobile/mbllists.aspx
41. Osorio JE, Huang CY, Kinney RM, Stinchcomb DT. Development of DENVax: a chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever. Vaccine. 2011;29(42):7251–60. Takeda’s DENVax candidate is currently undergoing phase 2 studies.
42. Haller A. Cooperation among First-to-Introduce Countries for Dengue Vaccines. Dengue Vaccine Initiative Conference of Likely First-to-Introduce Countries. Brasilia. 9–11 April 2013. http://www.denguevaccines.org/news-events/cooperation-among-first-introduce-countries-dengue-vaccines-2013-meeting
43. Inviragen Press Release: Dengue Vaccine Update: DENVax continues to advance through phase 2. Feb 2013. http://www.inviragen.com/press/DENVax %20advances %20to %20stage %202 %20FINAL.pdf
44. Cox J, Mota J, Sukupolvi-Petty S, Diamond M, Rico-Hesse R. Mosquito bite delivery of dengue virus enhances immunogenicity and pathogenesis in humanized mice. J Virol. 2012;86(14):7637–49.
45. Sun W, Cunningham D, Wasserman SS, et al. Phase 2 clinical trial of three formulations of tetravalent live-attenuated dengue vaccine in flavivirus-naïve adults. Human Vaccines. 2009;5(1):33–40.
46. Simasathien S, Thomas SJ, Watanaveeradej V, et al. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus naive children. Am J Trop Med Hyg. 2008;78(3):426–33.
47. Watanaveeradej V, Simasathien S, Nisalak A, et al. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus-naive infants. Am J Trop Med Hyg. 2011;85(2):341–51.
48. Thomas SJ, Eckels KH, Carletti I, et al. A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults. Am J Trop Med Hyg. 2013;88(1):73–88.
49. Watanaveeradej, V. et al. Am J Trop Med Hyg, in press.
50. Putnak R, Cassidy K, Conforti N, et al. Immunogenic and protective response in mice immunized with a purified, inactivated, Dengue-2 virus vaccine prototype made in fetal rhesus lung cells. Am J Trop Med Hyg. 1996;55(5):504–10.
51. Fernandez. Immunogenicity and Protection Elicited by Adjuvanted Tetravalent Dengue Virus Purified Inactivated Vacine (TDENV PIV) in Rhesus Macaques. ASTMH 61st Annual Meeting. November 11–15, 2012, Atlanta, Georgia, USA
52. Schmidt A. et al. abstract, ASTMH abstract number and author list pending
53. Clements DE, Ba C, Lieberman MM, et al. Development of recombinant tetravalent dengue virus vaccine: immunogenicity and efficacy studies in mice and monkeys. Vaccine. 2010;28(15):2705–15.
54. Roehrig JT Current status of dengue vaccine development. WHO: Strategic Advisory Group of Experts (SAGE) Meeting. 9–11 April 2013. www.who.int/immunization/sage/meeetings/2013/april/presentations_background_docs/en/index1.html
55. Kochel TJ, Raviprakash K, Hayes CG, et al. A dengue virus serotype-DNA vaccine induces neutralizing antibodies and provides protection from viral challenges in Aotus monkeys. Vaccine. 2000;18(27):3166–73.
56. Beckett GB, Tjaden J, Burgess T, et al. Evaluation of a prototype dengue-1 DNA vaccine in phase 1 clinical trials. Vaccine. 2011;29:960–8.
57. Porter KR, Ewing D, Chen L, et al. Immunogenicity and protective efficacy of a vexfectin-adjuvanted tetravalent dengue DNA vaccine. Vaccine. 2012;30(2):336–41.
58. Simmons M, Burgess T, Lynch J, Putnak R. Protection against dengue virus by non-replicating and live attenuated vaccines used together in a prime boost vaccination strategy. Virology. 2010;396(2):280–8.
59. Vorndam V, Beltran M. Enzyme-linked immunosorbent assay-format microneutralization test for dengue viruses. Am J Trop Med Hyg. 2002;66(2):208–12.
60. Chawla T, Chan KR, Zhang SL, et al. Dengue virus neutralization in cells expressing Fc gamma receptors. PLOS ONE. 2013;8(5):e65231.
61. Moi ML, Lim CK, Kotaki A, Takasaki T, Kurane I. Discrepancy in dengue virus neutralizing antibody titers between plaque reduction neutralizing tests with Fcgamma receptor (FcgammaR)-negative and FcgammaR-expressing BHK-21 cells. Clin Vaccine Immunol: CVI. Mar 2010;17(3):402–7.
62. Rodrigo WW, Alcena DC, Rose RC, Jin X, Schlesinger JJ. An automated Dengue virus microneutralization plaque assay performed in human Fc{gamma} receptor-expressing CV-1 cells. Am J Trop Med Hyg. 2009;80(1):61–5.
63. Thomas SJ, Hombach J, Barrett A. Scientific consultation on cell mediated immunity (CMI) in dengue and dengue vaccine development. Vaccine. 2009;27(3):355–68.
64. 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.
65. Rothman AL, Kanesa-thasan N, West K, Janus J, Saluzzo J, Ennis FA. Induction of T lymphocyte responses to dengue virus by a candidate tetravalent live attenuated dengue virus vaccine. Vaccine. 2001;19(32):4694–9.
66. Sun W, Eckels KH, Putnak JR, et al. Experimental dengue virus challenge of human subjects previously vaccinated with live attenuated tetravalent dengue vaccines. J Infect Dis. 2013;207:700–8. This study used a human challenge model to test dengue vaccine efficacy; it is the first to do so.
67. Durbin AP, Whitehead SS. The dengue human challenge model: has the time come to accept this challenge? J Infect Dis. 2013;207(5):697–9.