Development of DENVax: A chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever

Vaccine

Volumn 29, Issue 42, 2011, Pages 7251-7260

  Osorio, Jorge E ^a,b   Huang, Claire Y H ^c   Kinney, Richard M ^c   Stinchcomb, Dan T ^a,d  

^a Inviragen Inc   (United States)

^b School of Veterinary Medicine ^*

^c UNIVERSITY OF WISCONSIN MADISON   (United States)

^d NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES   (United States)

Author keywords

DEN 2 PDK 53 virus; Dengue fever; Dengue virus; Recombinant viral vaccine; Vaccine development

Indexed keywords

DENGUE VACCINE; DENGUE VIRUS 1 VACCINE; DENGUE VIRUS 2 VACCINE; DENGUE VIRUS 3 VACCINE; DENGUE VIRUS 4 VACCINE; PLACEBO; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANOREXIA; ARTHRALGIA; ARTICLE; CHIMERA; COLOMBIA; DENGUE; DENGUE VIRUS 1; DENGUE VIRUS 2; DENGUE VIRUS 3; DENGUE VIRUS 4; DRUG EFFICACY; DRUG SAFETY; ERYTHEMA; EXPERIMENTAL MODEL; EYE PAIN; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; LEUKOPENIA; MACULOPAPULAR RASH; MALAISE; MYALGIA; NAUSEA; NEUTROPENIA; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PRURITUS; RASH; SEROCONVERSION; SEROTYPE; SIDE EFFECT; SINGLE DRUG DOSE; THROMBOCYTOPENIA; VIRUS STRAIN;

ANIMALS; CLINICAL TRIALS, PHASE I AS TOPIC; DENGUE; DENGUE VACCINES; DENGUE VIRUS; HUMANS; MODELS, ANIMAL; VACCINES, ATTENUATED; VACCINES, SYNTHETIC;

EID: 80052418874     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.07.020     Document Type: Article

References (49)

1. Halstead S.B. Dengue. Lancet 2007, 370(November (9599)):1644-1652.
2. Halstead S.B. Dengue virus-mosquito interactions. Annu Rev Entomol 2008, 53:273-291.
3. Guzman M.G., Kouri G. Dengue: an update. Lancet Infect Dis 2002, 2(January (1)):33-42.
4. Wilder-Smith A., Gubler D.J. Geographic expansion of dengue: the impact of international travel. Med Clinics North America 2008, 92(November (6)):1377-1390.
5. Gubler D.J. Dengue/dengue haemorrhagic fever: history and current status. Novartis Found Symp 2006, 277:3-16. [discussion -22, 71-3, 251-3].
6. Guzman A., Isturiz R.E. Update on the global spread of dengue. Int J Antimicrob Agents 2010, 36(November (Suppl. 1)):S40-S42.
7. Kyle J.L., Harris E. Global spread and persistence of dengue. Annu Rev Microbiol 2008, 62:71-92.
8. Halstead S.B., Dengue Curr Opin Infect Dis 2002, 15(October (5)):471-476.
9. Halstead S.B., Heinz F.X., Barrett A.D., Roehrig J.T. Dengue virus: molecular basis of cell entry and pathogenesis, 25-27 June 2003, Vienna, Austria. Vaccine 2005, 23(January (7)):849-856.
10. Rosen L. The Emperor's new clothes revisited, or reflections on the pathogenesis of dengue hemorrhagic fever. Am J Trop Med Hyg 1977, 26(May (3)):337-343.
11. Rothman A.L. Immunology and immunopathogenesis of dengue disease. Adv Virus Res 2003, 60:397-419.
12. Halstead S.B., Chow J.S., Marchette N.J. Immunological enhancement of dengue virus replication. Nat New Biol 1973, 243(May (122)):24-26.
13. Halstead S.B., O'Rourke E.J. Dengue viruses and mononuclear phagocytes. I. Infection enhancement by non-neutralizing antibody. J Exp Med 1977, 146(July (1)):201-217.
14. Halstead S.B., Mahalingam S., Morovich M.A., Ubol S., Mosser D.M. Intrinsic antibody-dependent enhancement of microbial infection in macrophages: disease regulation by immune complexes. Lancet Infect Dis 2010, 10(October (10)):712-722.
15. Lorono-Pino M.A., Cropp C.B., Farfan J.A., Vorndam A.V., Rodriguez-Angulo E.M., Rosado-Paredes E.P., et al. Common occurrence of concurrent infections by multiple dengue virus serotypes. Am J Trop Med Hyg 1999, 61(November (5)):725-730.
16. Bhamarapravati N., Yoksan S. Live attenuated tetravalent vaccine. Dengue and dengue hemorraghic fever 1977, CAB International, Wallingford, UK, pp. 367-377. D.J. Gubler, G. Kuno (Eds.).
17. Whitehead S.S., Blaney J.E., Durbin A.P., Murphy B.R. Prospects for a dengue virus vaccine. Nat Rev Microbiol 2007, 5(July (7)):518-528.
18. Kitchener S., Nissen M., Nasveld P., Forrat R., Yoksan S., Lang J., et al. Immunogenicity and safety of two live-attenuated tetravalent dengue vaccine formulations in healthy Australian adults. Vaccine 2006, 24(February (9)):1238-1241.
19. Sun W., Cunningham D., Wasserman S.S., Perry J., Putnak J.R., Eckels K.H., et al. Phase 2 clinical trial of three formulations of tetravalent live-attenuated dengue vaccine in flavivirus-naive adults. Hum Vaccin 2009, 5(Jan-Feb (1)):33-40.
20. Guy B. Immunogenicity of sanofi pasteur tetravalent dengue vaccine. J Clin Virol 2009, 46(October (Suppl. 2)):S16-S19.
21. McArthur J.H., Durbin A.P., Marron J.A., Wanionek K.A., Thumar B., Pierro D.J., et al. Phase I clinical evaluation of rDEN4Delta30-200,201: a live attenuated dengue 4 vaccine candidate designed for decreased hepatotoxicity. Am J Trop Med Hyg 2008, 79(November (5)):678-684.
22. Clements D.E., Collar B.A., Lieberman M.M., Ogata S., Wang G., Harada K.E., et al. Development of a recombinant tetravalent dengue virus vaccine: immunogenicity and efficacy studies in mice and monkeys. Vaccine 2010, 28(March (15)):2705-2715.
23. Holman D.H., Wang D., Raviprakash K., Raja N.U., Luo M., Zhang J., et al. Two complex, adenovirus-based vaccines that together induce immune responses to all four dengue virus serotypes. Clin Vaccine Immunol 2007, 14(February (2)):182-189.
24. Raviprakash K., Wang D., Ewing D., Holman D.H., Block K., Woraratanadharm J., et al. A tetravalent dengue vaccine based on a complex adenovirus vector provides significant protection in rhesus monkeys against all four serotypes of dengue virus. J Virol 2008, 82(July (14)):6927-6934.
25. Beckett C.G., Tjaden J., Burgess T., Danko J.R., Tamminga C., Simmons M., et al. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine 2011, 29(January (5)):960-968.
26. Clements D.E., Coller B.A., Lieberman M.M., Ogata S., Wang G., Harada K.E., et al. Development of a recombinant tetravalent dengue virus vaccine: immunogenicity and efficacy studies in mice and monkeys. Vaccine 2010, 28(March (15)):2705-2715.
27. Apt D., Raviprakash K., Brinkman A., Semyonov A., Yang S., Skinner C., et al. Tetravalent neutralizing antibody response against four dengue serotypes by a single chimeric dengue envelope antigen. Vaccine 2006, 24(January (3)):335-344.
28. Yoksan S., Bhamarapravati N., Halstead S. Dengue virus vaccine development: study on biological markers of cloned dengue 1-4 viruses serially passaged in primary kidney cells. Arbovirus Research in Australia, Proceedings of the Fourth Symposium 1986, 35-38. CSIRO/QIMR, Brisbane, Australia. T.D. St. George, B.H. Kay, J. Blok (Eds.).
29. Butrapet S., Huang C.Y., Pierro D.J., Bhamarapravati N., Gubler D.J., Kinney R.M. Attenuation markers of a candidate dengue type 2 vaccine virus, strain 16681 (PDK-53), are defined by mutations in the 5' noncoding region and nonstructural proteins 1 and 3. J Virol 2000, 74(April (7)):3011-3019.
30. 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 1997, 230(April (2)):300-308.
31. Angsubhakorn S., Moe J.B., Marchette N.J., Palumbo N.E., Yoksan S., Bhamarapravati N. Neurovirulence effects of dengue-2 viruses on the rhesus (Macaca mulatta) brain and spinal cord. Southeast Asian J Tropical Med. Public Health 1987, 18(March (1)):52-55.
32. Bhamarapravati N., Yoksan S., Chayaniyayothin T., Angsubphakorn S., Bunyaratvej A. Immunization with a live attenuated dengue-2-virus candidate vaccine (16681- PDK 53): clinical, immunological and biological responses in adult volunteers. Bull World Health Organ 1987, 65(2):189-195.
33. 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 1996, 14(March (4)):329-336.
34. Bhamarapravati N., Yoksan S. Study of bivalent dengue vaccine in volunteers. Lancet 1989, 1(May (8646)):1077.
35. Bhamarapravati N., Sutee Y. Live attenuated tetravalent dengue vaccine. Vaccine 2000, 18(May (Suppl. 2)):44-47.
36. Kanesa-thasan N., Sun W., Kim-Ahn G., Van Albert S., Putnak J.R., King A., et al. Safety and immunogenicity of attenuated dengue virus vaccines (Aventis Pasteur) in human volunteers. Vaccine 2001, 19(April (23-24)):3179-3188.
37. Sabchareon A., Lang J., Chanthavanich P., Yoksan S., Forrat R., Attanath P., et al. Safety and immunogenicity of tetravalent live-attenuated dengue vaccines in Thai adult volunteers: role of serotype concentration, ratio, and multiple doses. Am J Trop Med Hyg 2002, 66(March (3)):264-272.
38. Sabchareon A., Lang J., Chanthavanich P., Yoksan S., Forrat R., Attanath P., et al. Safety and immunogenicity of a three dose regimen of two tetravalent live- attenuated dengue vaccines in five- to twelve-year-old Thai children. Pediatr Infect Dis J 2004, 23(February (2)):99-109.
39. Guy B., Chanthavanich P., Gimenez S., Sirivichayakul C., Sabchareon A., Begue S., et al. Evaluation by flow cytometry of antibody-dependent enhancement (ADE) of dengue infection by sera from Thai children immunized with a live-attenuated tetravalent dengue vaccine. Vaccine 2004, 22(September (27-28)):3563-3574.
40. Chanthavanich P., Luxemburger C., Sirivichayakul C., Lapphra K., Pengsaa K., Yoksan S., et al. Short report: immune response and occurrence of dengue infection in Thai children three to eight years after vaccination with live attenuated tetravalent dengue vaccine. Am J Trop Med Hyg 2006, 75(July (1)):26-28.
41. Huang C.Y., Butrapet S., Tsuchiya K.R., Bhamarapravati N., Gubler D.J. Kinney RM. Dengue 2 PDK-53 virus as a chimeric carrier for tetravalent dengue vaccine development. J Virol 2003, 77(November (21)):11436-11447.
42. Butrapet S., Kinney R.M., Huang C.Y. Determining genetic stabilities of chimeric dengue vaccine candidates based on dengue 2 PDK-53 virus by sequencing and quantitative TaqMAMA. J Virol Methods 2006, 131(January (1)):1-9.
43. Kinney R.M., Huang C.Y. Development of new vaccines against dengue fever and Japanese encephalitis. Intervirology 2001, 44(2-3):176-197.
44. Huang C.Y., Butrapet S., Pierro D.J., Chang G.J., Hunt A.R., Bhamarapravati N., et al. Chimeric dengue type 2 (vaccine strain PDK-53)/dengue type 1 virus as a potential candidate dengue type 1 virus vaccine. J Virol 2000, 74(April (7)):3020-3028.
45. Johnson A.J., Roehrig J.T. New mouse model for dengue virus vaccine testing. J Virol 1999, 73(January (1)):783-786.
46. Osorio J.E., Brewoo J., Silengo S.J., Arguello J., Moldovan I.R., Tary-Lehmann M., et al. Efficacy of a tetravalent chimeric dengue vaccine (DENVax) in cynomolgus macaques. Am J Trop Med Hyg 2011, 84(6):978-987.
47. Butrapet S., Rabablert J., Angsubhakorn S., Wiriyarat W., Huang C., Kinney R., et al. Chimeric dengue type 2/type 1 viruses induce immune responses in cynomolgus monkeys. Southeast Asian J. Tropical Med. Public Health 2002, 33(September (3)):589-599.
48. Halstead S.B., Simasthien P. Observations related to the pathogenesis of dengue hemorrhagic fever. II. Antigenic and biologic properties of dengue viruses and their association with disease response in the host. Yale J Biol Med 1970, 42(April (5)):276-292.
49. Gubler D.J., Nalim S., Tan R., Saipan H., Sulianti Saroso J. Variation in susceptibility to oral infection with dengue viruses among geographic strains of Aedes aegypti. Am J Trop Med Hyg 1979, 28(November (6)):1045-1052.