Safety evaluation of chimeric langat/dengue 4 flavivirus, a live vaccine candidate against tick-borne encephalitis

Journal of Medical Virology

Volumn 81, Issue 10, 2009, Pages 1777-1785

  Pripuzova, Natalia S ^a   Tereshkina, Natalia V ^b   Gmyl, Larissa V ^a   Dzhivanyan, Tatiana I ^a   Rumyantsev, Alexander A ^a   Romanova, Lidiya Iu ^a   Mustafina, Aida N ^a   Lashkevich, Vasilii A ^a   Karganova, Galina G ^a  

^a CHUMAKOV INSTITUTE OF POLIOMYELITIS AND VIRAL ENCEPHALITIDES   (Russian Federation)

^b Tarasevic State Institute for the Standardization and Control of Medical Biological Preparations   (France)

Author keywords

Attenuation; Flavivirus persistence; Neurovirulence in monkeys

Indexed keywords

LIVE VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CENTRAL NERVOUS SYSTEM; CHIMERA; CONTROLLED STUDY; DENGUE VIRUS; DRUG SAFETY; DRUG SCREENING; FEMALE; FLAVIVIRUS; INOCULATION; MONKEY; MOUSE; NONHUMAN; NUCLEOTIDE SEQUENCE; PERSISTENT VIRUS INFECTION; TICK BORNE ENCEPHALITIS; VIROGENESIS; VIROLOGY; VIRUS STRAIN; VIRUS VIRULENCE;

ANIMALS; CENTRAL NERVOUS SYSTEM; DENGUE VIRUS; ENCEPHALITIS VIRUSES, TICK-BORNE; ENCEPHALITIS, TICK-BORNE; FEMALE; FLAVIVIRUS; GENETIC VECTORS; HAPLORHINI; HUMANS; MALE; MICE; MICE, INBRED BALB C; UNITED STATES; VACCINES, SYNTHETIC; VIRAL VACCINES;

ANIMALIA; FLAVIVIRUS; IXODIDA; LANGAT VIRUS; MUS; SIMIAE;

EID: 69949165747     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.21587     Document Type: Article

References (53)

1. Arroyo J, Miller C, Catalan J, Myers GA, Ratterree MS, Trent DW, Monath TP. 2004. ChimeriVax-West Nile virus live-attenuated vaccine: Preclinical evaluation of safety, immunogenicity, and efficacy. J Virol 78:12497-12507. (Pubitemid 39458768)
2. Boulger LR. 1973. The neurovirulence test for live poliomyelitis vaccine. J Biol Stand 1:119-138.
3. Burke DS, Monath TP. 2001. Flaviviruses. In: Knipe DM, Howley PM, editors. Fields virology. 4th edition. Philadelphia: Lippincott-Raven Publishers. pp. 965-1030.
4. Dean CH, Alarcon JB, Waterston AM, Draper K, Early R, Guirakhoo F, Monath TP, Mikszta JA. 2005. Cutaneous delivery of a live, attenuated chimeric flavivirus vaccine against Japanese encephalitis (ChimeriVax)-JE) in non-human primates. Hum Vaccin 1:106-111.
5. Dragunsky E, Taffs R, Chernokhvostova Y, Nomura T, Hioki K, Gardner D, Norwood L, Levenbook I. 1996. A poliovirus-susceptible transgenic mouse model as a possible replacement for the monkey neurovirulence test of oral poliovirus vaccine. Biologicals 24:77-86. (Pubitemid 26335410)
6. Dremov D. 1977. Comparative patomorphological investigation of neurovirulence of attenuated tick-borne encephalitis virus variants in monkeys. In: Karpov SP, editor. Scientific basis of production of virological and bacteriological preparations. Tomsk: Tomsk University. pp. 95-112.
7. Dubov A, editor. 1969. Live vaccine against tick-borne encephalitis. Tyumen: Tyumen Scientific Research Institute of Regional Infectious Pathology. 161 pp.
8. Dubov A, editor. 1971. Trying out experience of the live vaccine against tick-borne encephalitis. Tyumen: Tyumen Scientific Research Institute of Regional Infectious Pathology. 172 pp.
9. Frolova MP, Pogodina VV. 1984. Persistence of tick-borne encephalitis virus in monkeys. VI. Pathomorphology of chronic infection in central nervous system. Acta Virol 28:232-239.
10. Frolova TV, Pogodina VV, Larina GI, Frolova MP, Karmysheva VI. 1982. Activating effect of cyclophosphane at late stages of persistence of the tick-borne encephalitis virus. Vopr Virusol 27:66-73.
11. Guirakhoo F, Pugachev K, Zhang Z, Myers G, Levenbook I, Drapper K, Lang J, Ocran S, Mitchell F, Parsons M, Brown N, Brandler S, Fournier C, Barrere B, Rizvi F, Travassos A, Nichols R, Trent D, Monath T. 2004a. Safety and efficacy of chimeric yellow fever-dengue virus tetravalent vaccine formulations in nonhuman primates. J Virol 78:4761-4775.
12. Guirakhoo F, Zhang Z, Myers G, Johnson BW, Pugachev K, Nichols R, Brown N, Levebook I, Draper K, Cyrek S, Lang J, Fournier C, Barrere B, Delagrave S, Monath TP. 2004b. A single amino acid substitution in the envelope protein of chimeric yellow fever-dengue 1 vaccine virus reduces neurovirulence for suckling mice and viremia/viscerotropism for monkeys. J Virol 78:9998-10008. (Pubitemid 39187118)
13. Guirakhoo F, Kitchener S, Morrison D, Forrat R, McCarthy K, Nichols R, Yoksan S, Duan X, Ermak TH, Kanesa-Thasan N, Bedford P, Lang J, Quentin-Millet MJ, Monath TP. 2006. Live attenuated chimeric yellow fever dengue type 2 (ChimeriVax-DEN2) vaccine: Phase I clinical trial for safety and immunogenicity: Effect of yellow fever pre-immunity in induction of cross neutralizing antibody responses to all 4 dengue serotypes. Hum Vaccin 2:60-67. (Pubitemid 43927159)
14. Il'enko VI, Smorodintsev AA, Prozorova IN, Platonov VG. 1968. Experience in the study of a live vaccine made from the TP-21 strain of Malayan Langat virus. Bull World Health Organ 39:425-431.
15. Kamalov I, editor. 1991. Live vaccine against tick-borne encephalitis - Problems and perspective. St.-Petersburg: St.-Petersburg Pasteur Institute. 113 pp.
16. Kleiter I, Jilg W, Bogdahn U, Steinbrecher A. 2007. Delayed humoral immunity in a patient with severe tick-borne encephalitis after complete active vaccination. Infection 35:26-29. (Pubitemid 46295038)
17. Kofler RM, Heinz FX, Mandl CW. 2004. A novel principle of attenuation for the development of new generation live flavivirus vaccines. Arch Virol Suppl 18:191-200.
18. Lai CJ, Monath TP. 2003. Chimeric flaviviruses: Novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res 61:469-509.
19. Levenbook IS, Chigirinsky AE, Robinzon IA, Dubov AV. 1970. Morphological investigation of neuropathogenicity of tick-borne encephalitis virus (strain Yelantsev) in monkey. In: Proceedings of a Conference of L.A.Tarasevich State Research Institute for Medical and Biologicals Preparations, Moscow, pp. 229-238.
20. Lorenz RJ, Bogel K. 1973. Methods of calculation. In: Kaplan MM, Koprowski H, editors. Laboratory techniques in rabies. Geneva: WHO. pp. 321-335.
21. Mandl CW, Iacono-Connors L, Wallner G, Holzmann H, Kunz C, Heinz FX. 1991. Sequence of the genes encoding the structural proteins of the low-virulence tick-borne flaviviruses Langat TP21 and Yelantsev. Virology 185:891-895.
22. Mandl CW, Holzmann H, Meixner T, Rauscher S, Stadler PF, Allison SL, Heinz FX. 1998. Spontaneous and engineered deletions in the 30 noncoding region of tick-borne encephalitis virus: Construction of highly attenuated mutants of a flavivirus. J Virol 72:2132-2140. (Pubitemid 28100769)
23. Mathenge EG, Parquet Mdel C, Funakoshi Y, Houhara S, Wong PF, Ichinose A, Hasebe F, Inoue S, Morita K. 2004. Fusion PCR generated Japanese encephalitis virus/dengue 4 virus chimera exhibits lack of neuroinvasiveness, attenuated neurovirulence, and a dual-flavi immune response in mice. J Gen Virol 85:2503-2513. (Pubitemid 39214346)
24. Maximova OA, Ward JM, Asher DM, St Claire M, Finneyfrock BW, Speicher JM, Murphy BR, Pletnev AG. 2008. Comparative neuropathogenesis and neurovirulence of attenuated flaviviruses in nonhuman primates. J Virol 82:5255-5268.
25. Mayer V. 1973. Humoral antibody response in volunteers given the live, highly attenuated "14" clone derived from Langat E5 virus. Acta Virol 17:367-367
26. Mayer V. 1975. Alive vaccine against tick-borne encephalitis: Integrated studies. I. Basic properties and behavior of the E5 "14" clone (Langat virus). Acta Virol 19:209-218.
27. Monath TP, Arroyo J, Levenbook I, Zhang Z-X, Catalan J, Draper K, Guirakhoo F. 2002. Single mutation in the flavivirus envelop protein hinge region increases neurovirulence for mice and monkeys but decreases viscerotropism for monkeys: Relevance to development and safety testing of live attenuated vaccines. J Virol 76:1932-1943. (Pubitemid 34094640)
28. Monath TP, Myers GA, Beck RA, Knauber M, Scappaticci K, Pullano T, Archambault WT, Catalan J, Miller C, Zhang ZX, Shin S, Pugachev K, Draper K, Levenbook IS, Guirakhoo F. 2005. Safety testing for neurovirulence of novel live attenuated flaviviruse vaccines: Infant mice provide an accurate surrogate for the test in monkeys. Biologicals 33:131-144. (Pubitemid 41208092)
29. Nathanson N, Harrington B. 1967. Experimental infection of monkeys with Langat virus. II. Turnover of circulating virus. Am J Epidemiol 85:494-502.
30. Nathanson N, Goldblatt D, Thind I, Davis M, Price WH. 1965. Histological studies of the monkey neurovirulence of group Barboviruses. I. A semiquantitative grading scale. Am J Epidemiol 82:359-381.
31. Nathanson N, Goldblatt D, Thind IS, Davis M, Price WH. 1966. Histological studies of the monkey neurovirulence of group B arboviruses. II. Selection of indicator centers. Am J Epidemiol 84:524-540.
32. Nathanson N, Thind I, O'Leary W, Price WH. 1968. Histological studies of the monkey neurovirulence of group B arboviruses. IV. Evaluation of an attenuated strain (E5) of Langat virus. Am J Epidemiol 88:103-111.
33. Pletnev AG. 2001. Infectious cDNA clone of attenuated Langat tickborne flavivirus (strain E5) and a 3′ deletion mutant constructed from it exhibit decreased neuroinvasiveness in immunodeficient mice. Virology 282:288-300.
34. Pletnev AG, Men R. 1998. Attenuation of the Langat tick-borne flavivirus by chimerization with mosquito-borne flavivirus dengue type 4. Proc Natl Acad Sci USA 95:1746-1751. (Pubitemid 28103465)
35. Pletnev AG, Karganova GG, Dzhivanyan TI, Lashkevich VA, Bray M. 2000. Chimeric Langat/Dengue viruses protect mice from heterologous challenge with the highly virulent strains of tick-borne encephalitis virus. Virology 274:26-31. (Pubitemid 30650679)
36. Pletnev AG, Bray M, Hanley KA, Speicher J, Elkins R. 2001. Tick-borne Langat/mosquito-borne dengue flavivirus chimera, a candidate to live attenuated vaccine for protection against disease caused by membersof the tick-borne encephalitis virus complex: Evaluation in rhesus monkeys and in mosquitoes. J Virol 75:8259-8267. (Pubitemid 32743698)
37. Pogodina VV, Frolova MP, Malenko GV, Fokina GI, Levina LS, Mamonenko LL, Koreshkova GV, Ralf NM. 1981. Persistence of tick-borne encephalitis virus in monkeys. I. Features of experimental infection. Acta Virol 25:337-343.
38. Price WH, Thind IS, Teasdall R, O'Leary W. 1970. Vaccination of human volunteers against Russian Spring-Summer (RSS) virus complex with attenuated Langat E5 virus. Bull World Health Organ 42:82-94.
39. Romanenko VV, Esunina MS, Kilyachina AS. 2007. Experience in implementing the mass immunization program against tick-borne encephalitis in the Sverdlovsk Region. Vopr Virusol 52:22-25.
40. Romanova LI, Kozlovskaia LI, Shevtsova AS, Karganova GG. 2006. Evidence for the absence of tick-borne encephalitis virus RNA in bioassays. Vopr Virusol 51:38-41. (Pubitemid 43287177)
41. Romanova LI, Gmyl AP, Dzhivanian TI, Bakhmutov DV, Lukashev AN, Gmyl LV, Rumyantsev AA, Burenkova LA, Lashkevich VA, Karganova GG. 2007. Microevolution of tick-borne encephalitis virus in course of host alternation. Virology 362:75-84.
42. Rumyantsev AA, Chanock RM, Murphy BR, Pletnev AG. 2006. Comparison of live and inactivated tick-borne encephalitis virus vaccines for safety, immunogenicity and efficacy in rhesus monkeys. Vaccine 24:133-143.
43. Sambrook J, Frithsch EF, Maniatis T, editors. 1989. Molecular cloning: A laboratory manual. New York: Cold Spring Harbor Laboratory Press.
44. Smorodintsev AA, Dubov AV. 1986. Tick-borne encephalitis and its prevention. Leningrad-Moscow: AMS USSR. 321 pp.
45. Sokolova ED, Kamalov II, Konovalov GV, Veigman NZ. 1994. The neurovirulence of variants of the Langat TP-21 virus in experiments on different species of lower monkeys. Vopr Virusol 39:116-119.
46. Thind IS, Price WH. 1966. A chick embryo attenuated strain (TP21 E5) of Langat virus. I. Virulence of the virus for mice and monkeys. Am J Epidemiol 84:193-212.
47. Timofeev AV, Karganova GG. 2003. Tick-borne encephalitis vaccine: From past to future. Moscow: Pronto Prints. 44 pp.
48. Vargin VV, Semenov BF. 1979. Characteristics of the response of mice with temporary immunodepression to the administration of live or inactivated vaccine against tick-borne encephalitis. Vopr Virusol 52-57.
49. World Health Organization. 1997. Dengue haemorrhagic fever: Diagnosis, treatment, prevention and control. Geneva: WHO.
50. Wright PF, Ankrah S, Henderson SE, Durbin AP, Speicher J, Whitehead SS, Murphy BR, Pletnev AG. 2008. Evaluation of the Langat/dengue 4 chimeric virus as a live attenuated tick-borne encephalitis vaccine for safety and immunogenicity in healthy adult volunteers. Vaccine 26:882-890.
51. Zlotnik I, Smith CE, Grant DP, Peacock S. 1970. The effect of immunosuppression on viral encephalitis, with special reference to cyclophosphamide. Br J Exp Pathol 51:434-439.
52. Zlotnik I, Grant DP, Carter GB, Batter-Yatton D. 1973. Subacute sclerosing encephalitis in adult hamsters infected with Langat virus. Br J Exp Pathol 54:29-39.
53. Zlotnik I, Grant DP. 1976. Further observations on subacute sclerosing encephalitis in adult hamsters: The effects of intranasal infections with Langat virus, measles virus and SSPE-measles virus. Br J Exp Pathol 57:49-66.