Development of a recombinant tetravalent dengue virus vaccine: Immunogenicity and efficacy studies in mice and monkeys

Vaccine

Volumn 28, Issue 15, 2010, Pages 2705-2715

  Clements, David E ^a   Coller, Beth Ann G ^a   Lieberman, Michael M ^a   Ogata, Steven ^a   Wang, Gordon ^a   Harada, Kent E ^a   Putnak, J Robert ^b   Ivy, John M ^a   McDonell, Michael ^a   Bignami, Gary S ^a   Peters, Iain D ^a   Leung, Julia ^a   Weeks Levy, Carolyn ^a   Nakano, Eileen T ^a   Humphreys, Tom ^a  

^a HAWAII BIOTECH INC   (United States)

^b Walter Reed Army Institute for Research   (United States)

Author keywords

Dengue; Envelope; Subunit; Vaccine

Indexed keywords

DENGUE VACCINE; DENGUE VIRUS TETRAVALENT VACCINE; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY RESPONSE; ARTICLE; CONTROLLED STUDY; DENGUE; DENGUE VIRUS; DROSOPHILA; DRUG EFFICACY; GLYCOSYLATION; IMMUNOGENICITY; MONKEY; MOUSE; NONHUMAN; PRIORITY JOURNAL; VIRUS STRAIN;

ADJUVANTS, IMMUNOLOGIC; ANIMALS; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CELL LINE; CHOLESTEROL; CRYSTALLOGRAPHY, X-RAY; DENGUE; DENGUE VACCINES; DENGUE VIRUS; DISEASE MODELS, ANIMAL; DROSOPHILA; DRUG COMBINATIONS; FEMALE; HUMANS; MACACA MULATTA; MALE; MICE; MICE, INBRED BALB C; PHOSPHOLIPIDS; PROTEIN FOLDING; PROTEIN STRUCTURE, TERTIARY; SAPONINS; VACCINES, SUBUNIT; VACCINES, SYNTHETIC; VIRAL ENVELOPE PROTEINS;

EID: 77649270249     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.01.022     Document Type: Article

References (65)

1. Halstead S.B. Pathogenesis of dengue: challenges to molecular biology. Science 239 (1988) 476-481
2. Rigau-Perez J.G., Clark G.G., Gubler D.J., Reiter P., Sanders E.J., and Vorndam A.V. Dengue and dengue haemorrhagic fever. Lancet 352 (1998) 971-977
3. Monath T.P., and Dengue:. The risk to developed and developing countries. Proc Natl Acad Sci 91 (1994) 2395-2400
4. Gubler D.J. The global emergence/resurgence of arboviral diseases as public health problems. Arch Med Res 33 (2002) 330-342
5. Rigau-Perez J.G., Gubler D.J., Vorndam A.V., and Clark G.G. Dengue surveillance-United States, 1986-1992. MMWR 43 (1994) 7-19
6. Gubler D.J., and Trent D.W. Emergence of epidemic dengue/dengue hemorrhagic fever as a public health problem in the Americas. Infectious Agents Dis 2 (1994) 383-393
7. Hayes E.B., and Gubler D.J. Dengue and dengue hermorrhagic fever. Pediatr Infect Dis J 11 (1992) 311-317
8. Halstead S.B. Observations related to pathogenesis of dengue hemorrhagic fever. VI. Hypotheses and discussion. Yale J Biol Med 42 (1970) 350-362
9. Sangkawibha N., Rojanasuphot S., Ahandrik S., Viriyapongse S., JatanasenS, Salitul V., et al. Risk factors in dengue shock syndrome: a prospective epidemiologic study in Rayong, Thailand. I. The 1980 outbreak. Am J Epidemiol 120 (1984) 653-669
10. Mongkolsapaya J., Dejnirattisai W., Xu X.N., Vasanawathana S., Tangthawornchaikul N., Chairunsri A., et al. Original antigenic sin and apoptosis in the pathogenesis of dengue hemorrhagic fever. Nat Med 9 (2003) 921-927
11. Putnak R. Progress in the development of recombinant vaccines against dengue and other arthropod-borne flaviviruses. In: Kurstak E. (Ed). Modern vaccinology (1994), Plenum Medical, NY 231-252
12. Cardosa M.J. Dengue vaccine design: issues and challenges. Br Med Bull 54 (1998) 395-405
13. Chambers T.J., Tsai T.F., Pervikov Y., and Monath T.P. Vaccine development against dengue and Japanese encephalitis: report of a World Health Organization meeting. Vaccine 15 (1997) 1494-1502
14. Polo S., Ketner G., Levis R., and Falgout B. Infectious RNA transcripts from full-length dengue virus type 2 cDNA clones made in yeast. J Virol 71 (1997) 5366-5374
15. Kinney R.M., Butrapet S., Chang G.J., Tsuchiya K.R., Roehrig J.T., Bhamarapravati N., et al. Construction of infectious cDNA clones for dengue 2 virus: strain 16681 and its attenuated vaccine derivative, strain PDK-53. Virology 230 (1997) 300-308
16. Bray M., Men R., and Lai C.J. Monkeys immunized with intertypic chimeric dengue viruses are protected against wild-type virus challenge. J Virol 70 (1996) 4162-4166
17. Bray M., and Lai C.J. Construction of intertypic chimeric dengue viruses by substitution of structural protein genes. Proc Natl Acad Sci U S A 88 (1991) 10342-10346
18. Vaughn D.W., Hoke C.H., Yoksan S., LaChance R., Innis B.L., Rice R.M., et al. Testing of a dengue 2 live-attenuated vaccine (strain 16681 PDK 53) in ten American volunteers. Vaccine 14 (1996) 329-336
19. Edelman R., Tacket C.O., Wasserman S.S., Vaughn D.W., Eckels K.H., Dubois D.R., et al. A live attenuated dengue-1 vaccine candidate (45AZ5) passaged in primary dog kidney cell culture is attenuated and immunogenic for humans. J Infect Dis 170 (1994) 1448-1455
20. Angsubhakorn S., Yoksan S., Pradermwong A., Nitatpattana N., Sahaphong S., and Bhamarapravati N. Dengue-3 (16562) PGMK 33 vaccine: neurovirulence, viremia, and immune responses in Macaca fascicularis. Southeast Asian J Trop Med Public Health 25 (1994) 554-559
21. Hoke C.H., Malinoski F.J., Eckels K.H., Scott R.M., Dubois D.R., Summers P.L., et al. Preparation of an attenuated dengue 4 (341750 Carib) virus vaccine. II. Safety and immunogenicity in humans. Am J Trop Med Hyg 43 (1990) 219-226
22. Gualano R.C., Pryor M.J., Cauchi M.R., Wright J., and Davidson A.D. Identification of a major determinant of mouse neurovirulence of dengue virus type 2 using stably cloned genomic-length cDNA. J Gen Virol 79 (1998) 437-446
23. Innis B.I., and Eckels K.H. Progress in development of a live-attenuated tetravalent dengue virus vaccine by the United States Army Medical Research and Materiel Command. Am J Trop Med Hyg 69 Suppl. 6 (2003) 1-4
24. Edelman R. Dengue and dengue vaccines. J Infect Dis 191 (2005) 650-653
25. Edelman R. Dengue vaccines approach the finish line. Clin Infect Dis 45 Suppl. 1 (2007) S56-S60
26. Lai C.-J., and Monath T.P. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Viral Res 61 (2003) 469-509
27. Halstead S.B., and Deen J. The future of dengue vaccines. Lancet 360 (2002) 1243-1246
28. Putnak R., Barvir D.A., Burrous J.M., Dubois D.R., D'Andrea V.M., Hoke C.H., et al. Development of a purified, inactivated, dengue-2 virus vaccine prototype in Vero cells: immunogenicity and protection in mice and rhesus monkeys. J Infect Dis 174 (1996) 1176-1184
29. Putnak R., Cassidy K., Conforti N., Lee R., Sollazzo D., Truong T., 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 55 (1996) 504-510
30. Putnak J.R., Coller B.-A., Voss D., Vaughn D.W., Clements D., Houng H.S., et al. Recombinant subunit protein and inactivated virus vaccines for dengue type-2 formulated with new adjuvants induce high-titered virus-neutralizing antibodies and confer protection against virus challenge in rhesus macaques. Vaccine 23 (2005) 4442-4452
31. Roehrig J.T., Bolin R.A., and Kelly R.G. Monoclonal antibody mapping of the envelope glycoprotein of the dengue 2 virus, Jamaica. Virology 246 (1998) 317-328
32. Beasley D.W., and Barrett A.D. Identification of neutralizing epitopes within structural domain III of the West Nile virus envelope protein. J Virol 76 (2002) 13097-13100
33. Oliphant T., Nybakken G.E., Engle M., Xu Q., Nelson C.A., Sukupolvi-Petty S., et al. Antibody recognition and neutralization determinants on domains I and II of West Nile Virus envelope protein. J Virol 80 (2006) 12149-12159
34. Modis Y., Ogata S., Clements D., and Harrison S.C. A ligand-binding pocket in the dengue virus envelope glycoprotein. Proc Natl Acad Sci U S A 100 (2003) 6986-6991
35. Modis Y., Ogata S., Clements D., and Harrison S.C. Variable surface epitopes in the crystal structure of dengue virus type 3 envelope glycoprotein. J Virol 79 2 (2005) 1223-1231
36. Delenda C., Frenkiel M.P., and Deubel V. Protective efficacy in mice of a secreted form of recombinant dengue-2 virus envelope protein produced in baculovirus infected insect cells. Arch Virol 139 (1994) 197-207
37. Putnak R., Feighny R., Burrous J., Cochran M., Hackett C., Smith G., et al. Dengue-1 virus envelope glycoprotein gene expressed in recombinant baculovirus elicits virus-neutralizing antibody in mice and protects them from virus challenge. Am J Trop Med Hyg 45 (1991) 159-167
38. Bielefeldt-Ohmann H., Beasley D.W.C., Fitzpatrick D.R., and Aaskov J.G. Analysis of a recombinant dengue-2 virus-dengue-3 virus hybrid envelope protein expressed in a secretory baculovirus system. J Gen Virol 78 (1997) 2723-2733
39. Staropoli I., Frenkiel M.-P., Megret F., and Deubel V. Affinity purified dengue-2 virus envelope glycoprotein induces neutralizing antibodies and protective immunity in mice. Vaccine 15 (1997) 1946-1954
40. Sugrue R.J., Fu J., Howe J., and Chan Y.-C. Expression of the dengue virus structural proteins in Pichia pastoris leads to the generation of virus-like particles. J Gen Virol 78 (1997) 1861-1866
41. Culp J.S., Johansen H., Hellmig B., Beck J., Matthews T.J., Delers A., et al. Regulated expression allows high level production and secretion of HIV-1 gp120 envelope glycoprotein in Drosophila Schneider cells. Bio/Technology 9 (1991) 173-177
42. Eckels K.H., Brandt W.E., Harrison V.R., McCown J.M., and Russell P.K. Isolation of a temperature-sensitive dengue-2 virus under conditions suitable for vaccine development. Infect Immun 14 (1976) 1221-1227
43. Hahn Y.S., Galler R., Hunkapiller T., Dalrymple J.M., Strauss J.H., and Strauss E.G. Nucleotide sequence of dengue 2 RNA and comparison of the encoded proteins with those of other flaviviruses. Virology 162 (1988) 167-180
44. Osatomi K., Fuke I., Tsuru D., Shiba T., Sakaki Y., and Sumiyoshi H. Nucleotide sequence of dengue type 3 virus genomic RNA encoding viral structural proteins. Virus Genes 2 (1988) 99-108
45. Zhao B., Mackow E., Buckler-White A., Markoff L., Chanock R.M., Lai C.J., et al. Cloning full-length dengue type 4 viral DNA sequences: analysis of genes coding for structural proteins. Virology 155 (1986) 77-88
46. Schneider I. Cell lines derived from late embryonic stages of Drosophila melanogaster. J Embryol Exp Morphol 27 (1972) 353-365
47. Ivey-Hoyle M., Culp J.S., Chaikin M.A., Hellmig B.D., Matthews T.J., Sweet R.W., et al. Envelope glycoproteins from biologically diverse isolates of immunodeficiency viruses have widely different affinities for CD4. Proc Natl Acad Sci U S A 88 (1991) 512-516
48. Wigler M., Sweet R., Sim G.K., Wold B., Pellicer A., Lacey E., et al. Transformation of mammalian cells with genes from procaryotes and eucaryotes. Cell 16 (1979) 777-785
49. Henchal E.A., Gentry M.K., McCown J.M., and Brandt W.E. Dengue virus-specific and flavivirus group determinants identified with monoclonal antibodies by indirect immunofluorescence. Am J Trop Med Hyg 31 4 (1982 Jul) 830-836
50. Gentry M.K., Henchal E.A., McCown J.M., Brandt W.E., and Dalrymple J.M. Identification of distinct antigenic determinants on dengue-2 virus using monoclonal antibodies. Am J Trop Med Hyg 31 3 Pt 1 (1982 May) 548-555
51. Russell P.K., Nisalak A., Sukhavachana P., and Vivona S. A plaque reduction test for dengue virus neutralizing antibodies. J Immunol 99 (1967) 285-290
52. Lanciotti R.S., Gubler D.J., and Trent D.J. Molecular evolution and phylogeny of dengue-4 viruses. J Gen Virol 78 (1997) 2279-2286
53. Kawano H., Rostapshov V., Rosen L., and Lai C.J. Genetic determinants of dengue type 4 virus neurovirulence for mice. J Virol 67 (1993) 6567-6575
54. Endy T.P., Nisalak A., Chunsuttitwat S., Vaughn D.W., Green S., Ennis F.A., et al. Relationship of preexisting dengue virus (DV) neutralizing antibody levels to viremia and severity of disease in a prospective cohort study of DV infection in Thailand. J Infect Dis 189 (2004) 990-1000
55. Zhang Y., Zhang W., Ogata S., Clements D., Strauss J.H., Baker T.S., et al. Conformational changes of the flavivirus E glycoprotein. Structure 12 (2004) 1607-1618
56. Pierson T.C., and Diamond M.S. Molecular mechanisms of antibody-mediated neutralisation of flavivirus infection. Exp Rev Mol Med 10 (2008) 1-13
57. Vaughn D.W., Green S., Kalayanarooj S., Innis B.L., Nimmannitya S., Suntayakorn S., et al. Dengue in the early fibrile phase: viremia and antibody responses. J Infect Dis 176 (1997) 322-330
58. Vaughn D.W., Green S., Kalayanarooj S., Nimmannitya S., Suntayakorn S., Endy T.P., et al. Dengue viremia titer, antibody response pattern, and virus serotype correlate with disease severity. J Infect Dis 181 (2000) 2-9
59. Libraty D.H., Endy T.P., Houng H.S., Green S., Kalayanarooj S., Suntayakorn S., et al. Differing influences of virus burden and immune activation on disease severity in secondary dengue-3 virus infections. J Infect Dis 1185 (2002) 1213-1221
60. Libraty D.H., Young P.R., Pickering D., Endy T.P., Kalayanarooj S., Green S., et al. High circulating levels of the dengue virus nonstructural protein NS1 early in dengue illness correlate with the development of dengue hemorrhagic fever. J Infect Dis 186 (2002) 1165-1168
61. Chanthavanich P., Luxemburger C., Sirivichayakul C., Lapphra K., Pengsaa K., Yoksan S., et al. Short report: immune response an occurrence of dengue infection in Thai children three to eight years after vaccination with live attenuated tetravalent dengue vaccine. Am J Trop Med Hyg 75 (2006) 26-28
62. Webster D.P., Farrar J., and Rowland-Jones S. Progress towards a dengue vaccine. Lancet Infect Dis 9 (2009) 678-687
63. Guy B., Guirakhoo F., Barban V., Higgs S., Monath T.P., and Lang J. Preclinical and clinical development of YFV 17D-based chimeric vaccines against dengue, West Nile and Japanese encephalitis viruses. Vaccine (2009) [Epub ahead of print]
64. Blaney J.E., Durbin A.P., Murphy B.R., and Whitehead S.S. Targeted mutagenesis as a rational approach to dengue virus vaccine development. Curr Top Microbiol Immunol 338 (2010) 145-158
65. Durbin A.P., and Whitehead S.S. Dengue vaccine candidates in development. Curr Top Microbiol Immunol 338 (2010) 129-143