Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial

American Journal of Tropical Medicine and Hygiene

Volumn 93, Issue 3, 2015, Pages 454-460

  Martinez, Luis Javier ^a   Lin, Leyi ^a   Blaylock, Jason M ^a   Lyons, Arthur G ^a   Bauer, Kristen M ^a   De La Barrera, Rafael ^a   Simmons, Monika ^a   Jarman, Richard G ^a   Currier, Jeffrey R ^a   Friberg, Heather ^a   Danko, Janine R ^a   Teneza Mora, Nimfa C ^a   Robert Putnak, J ^a   Eckels, Kenneth H ^a,b   Thomas, Stephen J ^a  

^a NAVAL MEDICAL RESEARCH CENTER   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM HYDROXIDE; DENGUE VACCINE; INACTIVATED VACCINE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; NEUTRALIZING ANTIBODY; VIRUS ANTIBODY;

ADULT; ANIMAL CELL; ANTIBODY DETECTION; ARTICLE; DENGUE; DENGUE VIRUS 1; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; MALE; MYALGIA; NAUSEA; NONHUMAN; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; VACCINATION; VIRUS NEUTRALIZATION; VOMITING; ADOLESCENT; CLINICAL TRIAL; DENGUE VIRUS; IMMUNOLOGY; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; DENGUE VACCINES; DENGUE VIRUS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; MALE; MIDDLE AGED; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 84941659249     PISSN: 00029637     EISSN: 14761645     Source Type: Journal    
DOI: 10.4269/ajtmh.14-0819     Document Type: Article

References (30)

1. Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GRW, Simmons CP, Scott TW, Farrar JJ, Hay SI, 2013. The global distribution and burden of dengue. Nature 496: 504-507.
2. WHO, 2012. Dengue and Severe Dengue. Fact Sheet No. 117. Available at: http://www.who.int/mediacentre/factsheets/fs117/en/index.html. Accessed January 2012.
3. Centers for Disease Control and Prevention, 1994. Dengue fever among U.S. military personnel-Haiti. JAMA 273: 14-15.
4. Shepard DS, Suaya JA, Halstead SB, Nathan MB, Gubler DJ, Mahoney RT, Wang DNC, Meltzer MI, 2004. Cost-effectiveness of a pediatric dengue vaccine. Vaccine 2 2: 1275-1280.
5. Thomas SJ, 2011. The necessity and quandaries of dengue vaccine development. J Infect Dis 203: 299-303.
6. WHO, 2009. Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control. New edition. Available at: http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf.
7. Thomas SJ, 2014. Developing a dengue vaccine: progress and future challenges. Ann N Y Acad Sci 1323: 140-159.
8. Wallace D, Canouet V, Garbes P, Wartel TA, 2013. Challenges in the clinical development of a dengue vaccine. Current Opinion in Virology 3: 352-356.
9. Halstead SB, 2013. Identifying protective dengue vaccines: guide to mastering an empirical process. Vaccine 31: 4501-4507.
10. Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C, Reynales H, Costa MS, Morales-Ramirez JO, Carrasquilla G, Rey LC, Dietze R, Luz K, Rivas E, Montoya MC, Supelano MC, Zambrano B, Langevin E, Boaz M, Tornieporth N, Saville M, Noriega F, 2014. Efficacy of a tetra-valent dengue vaccine in children in Latin America. N Eng J Med 372: 113-123.
11. Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, Luong CQ, Rusmil K, Wirawan DN, Nallusamy R, Pitisuttithurn P, Thisyakorn U, Yoon IK, van der Vliet D, Langevin E, Laot T, Hutagalung Y, Frago C, Boaz M, Wartel TA, Tornieporth NG, Saville M, Bouckenooghe A, 2014. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: A phase 3, randomized, observer-masked, placebo-controlled trial. Lancet 384: 1358-1365.
12. Coller BAG, Clements DE, Bett AJ, Sagar SL, Ter Meulen JH, 2011. The development of recombinant subunit envelope-based vaccines to protect against dengue virus induced disease. Vaccine 29: 7267-7275.
13. Putnak R, Barvir D, Burrous J, Dubois D, Dandrea V, Hoke C, Sadoff J, Eckels K, 1996. Development of a purified, inactivated dengue 2 virus vaccine prototype in Vero cells: immunogenicity and protection in mice and rhesus macaques. J Infect Dis 174: 1176-1184.
14. Putnak JR, Coller BA, Voss G, Vaughn DW, Clements D, Peters I, Bignami G, Houng HS, Chen RC, Barvir DA, Seriwatana J, Cayphas S, Garcon N, Gheysen D, Kanesa-Thasan N, McDonell M, Humphreys T, Eckels KH, Prieels JP, Innis BL, 2005. An evaluation of dengue type-2 inactivated, recombi-nant subunit, and live-attenuated vaccine candidates in the rhesus macaque model. Vaccine 23: 4442-4452.
15. Simmons M, Porter KR, Hayes CG, Vaughn DW, Putnak R, 2006. 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 80: 9577-9585.
16. Simmons M, Burgess T, Lynch J, Putnak R, 2010. Protection against dengue virus by non-replicating and live attenuated vaccines used together in a prime boost vaccination strategy. Virology 396: 280-288.
17. Lyons A, Kanesa-thasan N, Kuschner RA, Eckels KH, Putnak R, Sun W, Burge R, Towle AC, Wilson P, Tauber E, Vaughn DW, 2007. A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis. Vaccine 25: 3445-3453.
18. Tauber E, Kollaritsch H, Korinek M, Rendi-Wagner P, Jilma B, Firbas C, Schranz S, Jong E, Klingler A, Dewasthaly S, Klade CS, 2007. Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: A non-inferiority, phase III, randomized controlled trial. Lancet 370: 1847-1853.
19. Duggan ST, Plosker GL, 2009. Japanese encephalitis vaccine (inactivated, adsorbed) [IXIARO]. Drugs 69: 115-122.
20. Kunz C, 2003. TBE vaccination and the Austrian experience. Vaccine 21: S150-S155.
21. Fischer M, Yendell SJ, Rollin PE, 2013. Tickborne Encephalitis. CDC Health Information for International Travel 2014: The Yellow Book. 60.1: 304.
22. Eckels KH, Putnak RP, 2003. Formalin-inactivated whole virus and recombinant subunit flavivirus vaccines. Adv Virus Res 61: 395-418.
23. Yauch LE, Shresta S, 2014. Dengue virus vaccine development. Adv Virus Res 88: 315-372.
24. Zompi S, Montoya M, Pohl MO, Balmaseda A, Harris E, 2012. Dominant crossreactive B cell response during secondary acute dengue virus infection in humans. PLoS NTD 6: 1-14.
25. Puschnik A, Lau L, Cromwell EA, Balmaseda A, Zompi S, 2013. Correlation between dengue-specific neutralizing antibodies and serum avidity in primary and secondary dengue virus 3 natural infections in humans. PLoS Negl Trop Dis 7: e2274.
26. Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, Putnak R, Toussaint J-F, Sun W, Bauer K, Gibbons RV, Innis BL, 2013. 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 88: 73-88.
27. Breukels MA, Joi-van der Zijde EM, van Tol MJD, Rijkers GT, 2002. Concentration and avidity of anti-Haemophilus influenzae type B (Hib) antibodies in serum samples obtained from patients for whom Hib vaccination failed. Clin Infect Dis 34: 191-197.
28. Zlamy M, Wurzner R, Holzmann H, Brandstatter A, Jeller V, Zimmerhackl LB, Prelog M, 2010. Antibody dynamics after tick-borne encephalitis and measles-mumps-rubella vaccination in children post early thymectomy. Vaccine 2 8: 8053-8060.
29. Mercader S, Garcia P, Bellini WJ, 2012. Measles virus IgG avidity assay for use in classification of measles vaccine failure in measles elimination settings. Clin Vaccine Immunol 19: 1810-1817.
30. Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL, 2014. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine 32: 3232-3236.