Preclinical development of a dengue tetravalent recombinant subunit vaccine: Immunogenicity and protective efficacy in nonhuman primates

Vaccine

Volumn 33, Issue 33, 2015, Pages 4105-4116

  Govindarajan, Dhanasekaran ^a   Meschino, Steven ^a   Guan, Liming ^a   Clements, David E ^b   ter Meulen, Jan H ^c   Casimiro, Danilo R ^a   Coller, Beth Ann G ^a   Bett, Andrew J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b HAWAII BIOTECH INC   (United States)

^c Immune Design   (United States)

Author keywords

Dengue; Efficacy; Envelope; Immunogenicity; Subunit vaccine

Indexed keywords

ALUMINUM HYDROXIDE; DEN 1 80E; DEN2 80E; DEN3 80E; DEN4 80E; DEN4 80EZIP; DENGUE VACCINE; ISCOM; NEUTRALIZING ANTIBODY; SUBUNIT VACCINE; UNCLASSIFIED DRUG; CHOLESTEROL; DRUG COMBINATION; IMMUNOLOGICAL ADJUVANT; ISCOMATRIX; PHOSPHOLIPID; RECOMBINANT VACCINE; SAPONIN; VACCINE; VIRUS ANTIBODY;

ADULT; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DENGUE; DENGUE VIRUS 1; DENGUE VIRUS 2; DENGUE VIRUS 3; DENGUE VIRUS 4; DRUG EFFICACY; DRUG FORMULATION; DRUG MEGADOSE; DRUG SCREENING; EXPERIMENTAL MONKEY; IMMUNOGENICITY; IN VITRO STUDY; LOW DRUG DOSE; NONHUMAN; PRIORITY JOURNAL; PROPHYLAXIS; SEROTYPE; TREATMENT DURATION; VACCINATION; VERO CELL LINE; VIRUS DETECTION; VIRUS NEUTRALIZATION; ANIMAL; BLOOD; DISEASE MODEL; DRUG COMBINATION; FEMALE; IMMUNIZATION; IMMUNOLOGY; MALE; PRECLINICAL STUDY; RHESUS MONKEY; VIREMIA;

ADJUVANTS, IMMUNOLOGIC; ANIMALS; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CHOLESTEROL; DENGUE; DENGUE VACCINES; DISEASE MODELS, ANIMAL; DRUG COMBINATIONS; DRUG EVALUATION, PRECLINICAL; FEMALE; IMMUNIZATION SCHEDULE; MACACA MULATTA; MALE; PHOSPHOLIPIDS; SAPONINS; VACCINES, COMBINED; VACCINES, SUBUNIT; VACCINES, SYNTHETIC; VIREMIA;

EID: 84952638920     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.06.067     Document Type: Article

References (38)

1. WHO Global strategy for dengue and prevention and control 2012-2020 2012, World Health Organization, Geneva.
2. Anderson K.B., Chunsuttiwat S., Nisalak A., Mammen M.P., Libraty D.H., Rothman A.L., et al. Burden of symptomatic dengue infection in children at primary school in Thailand: a prospective study. Lancet 2007, 369(April (9571)):1452-1459.
3. Halstead S.B., Suaya J.A., Shepard D.S. The burden of dengue infection. Lancet 2007, 369(April (9571)):1410-1411. PMID: 17467495. 10.1016/S0140-6736(07)60645-X.
4. Gubler D.J. The emergence of dengue/dengue hemorrhagic fever as a global public health problem. Factors in the emergence of arbovirus diseases 1997, 83-92. Elsevier, Paris, France. J.F. Saluzzo, B. Dodet (Eds.).
5. Bhatt S., Gething P.W., Brady O.J., Messina J.P., Farlow A.W., Moyes C.L., et al. The global distribution and burden of dengue. Nature 2013, 496(April (7446)):504-507. 10.1038/nature12060.
6. Brady O.J., Gething P.W., Bhatt S., Messina J.P., Brownstein J.S., Hoen A.G., et al. Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis 2012, 6(8):e1760. 10.1371/journal.pntd.0001760.
7. Burke D.S., Monath T.P. Flaviviruses. Fields virology 2001, 1043-1125. Lippincott Williams & Wilkins. D.M. Knipe, P.M. Howley (Eds.).
8. Endy T.P., Chunsuttiwat S., Nisalak A., Libraty D.H., Green S., Rothman A.L., et al. Epidemiology of inapparent and symptomatic acute dengue virus infection: a prospective study of primary school children in Kamphaeng Phet, Thailand. Am J Epidemiol 2002, 156(July (1)):40-51. 10.1093/aje/kwf005.
9. Coller B.A., Clements D.E. Dengue vaccines: progress and challenges. Curr Opin Immunol 2011, 23(June (3)):391-398. 10.1016/j.coi.2011.03.005.
10. Halstead S.B. Identifying protective dengue vaccines: guide to mastering an empirical process. Vaccine 2013, 31(September (41)):4501-4507. 10.1016/j.vaccine.2013.06.079.
11. 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. 10.1038/nrmicro1690.
12. WHO Dengue: guidelines for diagnosis, treatment, prevention and control 2009, WHO/HTM/NTD/DEN/2009.1, World Health Organization.
13. Thomas S.J., Endy T.P. Vaccines for the prevention of dengue: development update. Hum Vaccines 2011, 7(6):674-684.
14. Durbin A.P., Whitehead S.S. Next-generation dengue vaccines: novel strategies currently under development. Viruses 2011, 3(10):800-1814.
15. Durbin A.P., Whitehead S.S. Dengue vaccine candidates in development. Curr Top Microbiol Immunol 2010, 338:129-143.
16. Villar L., Dayan G.H., Arredondo-García J.L., Rivera D.M., Cunha R., Deseda C., et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015, 372(January (2)):113-123. 10.1056/NEJMoa1411037.
17. Capeding M.R., Tran N.H., Hadinegoro S.R., Ismail H.I., Chotpitayasunondh T., Chua M.N., 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(October (9951)):1358-1365. 10.1016/S0140-6736(14)61060-6.
18. Sabchareon A., Wallace D., Sirivichayakul C., Limkittikul K., Chanthavanich P., Suvannadabba S., 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(November (9853)):1559-1567. 10.1016/S0140-6736(12)61428-7.
19. Halstead S.B. Dengue vaccine development: a 75% solution?. Lancet 2012, 380(November (9853)):1535-1536. 10.1016/S0140-6736(12)61510-4.
20. Coller B.A., Clements D.E., Bett A.J., Sagar S.L., Ter Meulen J.H. The development of recombinant subunit envelope-based vaccines to protect against dengue virus induced disease. Vaccine 2011, 29(September (42)):7267-7275. 10.1016/j.vaccine.2011.07.021.
21. 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. 10.1016/j.vaccine.2010.01.022.
22. Henchal E.A., Gentry M.K., McCown J.M., Brandt W.E. Dengue virus-specific and flavivirus group determinants identified with monoclonal antibodies by indirect immunofluorescence. Am J Trop Med Hyg 1982, 31(July (4)):830-836.
23. Drane D., Gittleson C., Boyle J., Maraskovsky E. ISCOMATRIX™ adjuvant for prophylactic and therapeutic vaccines. Exp Rev Vaccines 2007, 6:761-772.
24. Roehrig J.T., Hombach J., Barrett A.D. Guidelines for plaque-reduction neutralization testing of human antibodies to dengue viruses. Viral Immunol 2008, 21(June (2)):123-132. 10.1089/vim.2008.0007.
25. 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(January (2)):280-288. 10.1016/j.virol.2009.10.023.
26. Robert Putnak J., Coller B.A., Voss G., Vaughn D.W., Clements D., Peters I., et al. An evaluation of dengue type-2 inactivated, recombinant subunit, and live-attenuated vaccine candidates in the rhesus macaque model. Vaccine 2005, 23(August (35)):4442-4452.
27. Duewell P., Kisser U., Heckelsmiller K., Hoves S., Stoitzner P., Koernig S., et al. ISCOMATRIX adjuvant combines immune activation with antigen delivery to dendritic cells in vivo leading to effective cross-priming of CD8+ T cells. J Immunol 2011, 187(July (1)):55-63. 10.4049/jimmunol.1004114.
28. Morelli A.B., Becher D., Koernig S., Silva A., Drane D., Maraskovsky E. ISCOMATRIX: a novel adjuvant for use in prophylactic and therapeutic vaccines against infectious diseases. J Med Microbiol 2012, 61(July (Pt 7)):935-943. 10.1099/jmm.0.040857-0.
29. Simmons M., Porter K.R., Hayes C.G., Vaughn D.W., Putnak R. Characterization of antibody responses to combinations of a dengue virus type 2 DNA vaccine and two dengue virus type 2 protein vaccines in rhesus macaques. J Virol 2006, 80(October (19)):9577-9585.
30. Blaney J.E., Matro J.M., Murphy B.R., Whitehead S.S. Recombinant, live-attenuated tetravalent dengue virus vaccine formulations induce a balanced, broad, and protective neutralizing antibody response against each of the four serotypes in rhesus monkeys. J Virol 2005, 79(May (9)):5516-5528.
31. Guirakhoo F., Arroyo J., Pugachev K.V., Miller C., Zhang Z.X., Weltzin R., et al. Construction, safety and immunogenicity in nonhuman primates of a chimeric yellow fever-dengue virus tetravalent vaccine. J Virol 2001, 75(August (16)):7290-7304. 10.1123/JVI.75.16.7290-7304.2001.
32. Eisenbarth S.C., Colegio O.R., O'Connor W., Sutterwala F.S., Flavell R.A. Crucial role for the Nalp3 inflammasome in the immunostimulatory properties of aluminium adjuvants. Nature 2008, 453(June (7198)):1122-1126. 10.1038/nature06939.
33. Ghimire T.R., Benson R.A., Garside P., Brewer J.M. Alum increases antigen uptake, reduces antigen degradation and sustains antigen presentation by DCs in vitro. Immunol Lett 2012, 147(September (1-2)):55-62. 10.1016/j.imlet.2012.06.002.
34. Guirakhoo F., Pugachev K., Zhang Z., Myers G., Levenbook I., Draper K., et al. Safety and efficacy of chimeric yellow Fever-dengue virus tetravalent vaccine formulations in nonhuman primates. J Virol 2004, 78(May (9)):4761-4775.
35. 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 1996, 174(December (6)):1176-1184.
36. 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 2004, 189(March (6)):990-1000.
37. Weiskopf D., Sette A. T-cell immunity to infection with dengue virus in humans. Front Immunol 2014, March (5):93. 10.3389/fimmu.2014.00093.
38. Thomas S.J., Endy T.P. Vaccines for the prevention of dengue. Human Vaccines 2011, June (6):675-684.