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Volumn 28, Issue 50, 2010, Pages 7993-8000

Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials

Author keywords

Attenuated vaccines; Clinical trial, phase 3; Japanese encephalitis vaccines

Indexed keywords

JAPANESE ENCEPHALITIS VACCINE; JE CV; JE CV VACCINE; LIVE VACCINE; MBD JE VACCINE; PLACEBO; UNCLASSIFIED DRUG;

EID: 78650253263     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.09.035     Document Type: Article
Times cited : (56)

References (33)
  • 1
    • 0034724144 scopus 로고    scopus 로고
    • New initiatives for the control of Japanese encephalitis by vaccination: minutes of a WHO/CVI meeting, Bangkok, Thailand, 13-15 October 1998
    • Tsai T.F. New initiatives for the control of Japanese encephalitis by vaccination: minutes of a WHO/CVI meeting, Bangkok, Thailand, 13-15 October 1998. Vaccine 2000, 18(Suppl. 2):1-25.
    • (2000) Vaccine , vol.18 , Issue.SUPPL. 2 , pp. 1-25
    • Tsai, T.F.1
  • 2
    • 33747753182 scopus 로고    scopus 로고
    • Japanese encephalitis vaccines
    • World Health Organization
    • World Health Organization Japanese encephalitis vaccines. Wkly Epidemiol Rec 2006, 81(34-35):331-340.
    • (2006) Wkly Epidemiol Rec , vol.81 , Issue.34-35 , pp. 331-340
  • 3
    • 13444294448 scopus 로고    scopus 로고
    • Japanese encephalitis vaccine
    • Saunders, Philadelphia, S.A. Plotkin, W.A. Orenstein (Eds.)
    • Halstead S.B., Tsai T.F. Japanese encephalitis vaccine. Vaccines 2004, 919-958. Saunders, Philadelphia. 4th ed. S.A. Plotkin, W.A. Orenstein (Eds.).
    • (2004) Vaccines , pp. 919-958
    • Halstead, S.B.1    Tsai, T.F.2
  • 4
    • 0000654676 scopus 로고    scopus 로고
    • Vaccination against Japanese encephalitis in the Torres Straight
    • Hanna J., Barnett D., Ewald D. Vaccination against Japanese encephalitis in the Torres Straight. Commun Dis Intel 1996, 20(8):188-190.
    • (1996) Commun Dis Intel , vol.20 , Issue.8 , pp. 188-190
    • Hanna, J.1    Barnett, D.2    Ewald, D.3
  • 6
    • 24044524522 scopus 로고    scopus 로고
    • Global advisory committee on vaccine safety, 9-10 June 2005
    • Global advisory committee on vaccine safety, 9-10 June 2005. Wkly Epidemiol Rec 2005, 80(28):242-247.
    • (2005) Wkly Epidemiol Rec , vol.80 , Issue.28 , pp. 242-247
  • 7
    • 10544222250 scopus 로고    scopus 로고
    • Effectiveness of live-attenuated Japanese encephalitis vaccine (SA14-14-2): a case-control study
    • Hennessy S., Liu Z., Tsai T.F., Strom B.L., Wan C.M., Liu H.L., et al. Effectiveness of live-attenuated Japanese encephalitis vaccine (SA14-14-2): a case-control study. Lancet 1996, 347(9015):1583-1586.
    • (1996) Lancet , vol.347 , Issue.9015 , pp. 1583-1586
    • Hennessy, S.1    Liu, Z.2    Tsai, T.F.3    Strom, B.L.4    Wan, C.M.5    Liu, H.L.6
  • 8
    • 34250028171 scopus 로고    scopus 로고
    • Single dose of SA14-14-2 vaccine provides long-term protection against Japanese encephalitis: a case-control study in Nepalese children 5 years after immunization
    • Tandan J.B., Ohrr H., Sohn Y.M., Yoksan S., Ji M., Nam C.M., et al. Single dose of SA14-14-2 vaccine provides long-term protection against Japanese encephalitis: a case-control study in Nepalese children 5 years after immunization. Vaccine 2007, 25(27):5041-5045.
    • (2007) Vaccine , vol.25 , Issue.27 , pp. 5041-5045
    • Tandan, J.B.1    Ohrr, H.2    Sohn, Y.M.3    Yoksan, S.4    Ji, M.5    Nam, C.M.6
  • 9
    • 36549069631 scopus 로고    scopus 로고
    • Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial
    • Tauber E., Kollaritsch H., Korinek M., Rendi-Wagner P., Jilma B., Firbas C., et al. Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial. Lancet 2007, 370(9602):1847-1853.
    • (2007) Lancet , vol.370 , Issue.9602 , pp. 1847-1853
    • Tauber, E.1    Kollaritsch, H.2    Korinek, M.3    Rendi-Wagner, P.4    Jilma, B.5    Firbas, C.6
  • 11
    • 4143125552 scopus 로고    scopus 로고
    • Protection against Japanese encephalitis virus strains representing four genotypes by passive transfer of sera raised against ChimeriVax-JE experimental vaccine
    • Beasley D.W., Li L., Suderman M.T., Guirakhoo F., Trent D.W., Monath T.P., et al. Protection against Japanese encephalitis virus strains representing four genotypes by passive transfer of sera raised against ChimeriVax-JE experimental vaccine. Vaccine 2004, 22(27-28):3722-3726.
    • (2004) Vaccine , vol.22 , Issue.27-28 , pp. 3722-3726
    • Beasley, D.W.1    Li, L.2    Suderman, M.T.3    Guirakhoo, F.4    Trent, D.W.5    Monath, T.P.6
  • 12
    • 33646244630 scopus 로고    scopus 로고
    • Cutaneous delivery of a live, attenuated chimeric flavivirus vaccine against Japanese encephalitis (ChimeriVax)-JE) in non-human primates
    • Dean C.H., Alarcon J.B., Waterston A.M., Draper K., Early R., Guirakhoo F., et al. Cutaneous delivery of a live, attenuated chimeric flavivirus vaccine against Japanese encephalitis (ChimeriVax)-JE) in non-human primates. Hum Vaccine 2005, 1(3):106-111.
    • (2005) Hum Vaccine , vol.1 , Issue.3 , pp. 106-111
    • Dean, C.H.1    Alarcon, J.B.2    Waterston, A.M.3    Draper, K.4    Early, R.5    Guirakhoo, F.6
  • 13
    • 0033541937 scopus 로고    scopus 로고
    • Immunogenicity, genetic stability, and protective efficacy of a recombinant, chimeric yellow fever-Japanese encephalitis virus (ChimeriVax-JE) as a live, attenuated vaccine candidate against Japanese encephalitis
    • Guirakhoo F., Zhang Z.X., Chambers T.J., Delagrave S., Arroyo J., Barrett A.D., et al. Immunogenicity, genetic stability, and protective efficacy of a recombinant, chimeric yellow fever-Japanese encephalitis virus (ChimeriVax-JE) as a live, attenuated vaccine candidate against Japanese encephalitis. Virology 1999, 257(2):363-372.
    • (1999) Virology , vol.257 , Issue.2 , pp. 363-372
    • Guirakhoo, F.1    Zhang, Z.X.2    Chambers, T.J.3    Delagrave, S.4    Arroyo, J.5    Barrett, A.D.6
  • 14
    • 0033538089 scopus 로고    scopus 로고
    • Recombinant, chimaeric live, attenuated vaccine (ChimeriVax) incorporating the envelope genes of Japanese encephalitis (SA14-14-2) virus and the capsid and nonstructural genes of yellow fever (17D) virus is safe, immunogenic and protective in non-human primates
    • Monath T.P., Soike K., Levenbook I., Zhang Z.X., Arroyo J., Delagrave S., et al. Recombinant, chimaeric live, attenuated vaccine (ChimeriVax) incorporating the envelope genes of Japanese encephalitis (SA14-14-2) virus and the capsid and nonstructural genes of yellow fever (17D) virus is safe, immunogenic and protective in non-human primates. Vaccine 1999, 17(15-16):1869-1882.
    • (1999) Vaccine , vol.17 , Issue.15-16 , pp. 1869-1882
    • Monath, T.P.1    Soike, K.2    Levenbook, I.3    Zhang, Z.X.4    Arroyo, J.5    Delagrave, S.6
  • 15
    • 0033947590 scopus 로고    scopus 로고
    • Chimeric yellow fever virus 17D-Japanese encephalitis virus vaccine: dose-response effectiveness and extended safety testing in rhesus monkeys
    • Monath T.P., Levenbook I., Soike K., Zhang Z.X., Ratterree M., Draper K., et al. Chimeric yellow fever virus 17D-Japanese encephalitis virus vaccine: dose-response effectiveness and extended safety testing in rhesus monkeys. J Virol 2000, 74(4):1742-1751.
    • (2000) J Virol , vol.74 , Issue.4 , pp. 1742-1751
    • Monath, T.P.1    Levenbook, I.2    Soike, K.3    Zhang, Z.X.4    Ratterree, M.5    Draper, K.6
  • 16
    • 2942744421 scopus 로고    scopus 로고
    • A chimeric live attenuated vaccine against Japanese encephalitis
    • Jones T. A chimeric live attenuated vaccine against Japanese encephalitis. Expert Rev Vaccines 2004, 3(3):243-248.
    • (2004) Expert Rev Vaccines , vol.3 , Issue.3 , pp. 243-248
    • Jones, T.1
  • 17
    • 18544410924 scopus 로고    scopus 로고
    • Clinical proof of principle for ChimeriVax: recombinant live, attenuated vaccines against flavivirus infections
    • Monath T.P., McCarthy K., Bedford P., Johnson C.T., Nichols R., Yoksan S., et al. Clinical proof of principle for ChimeriVax: recombinant live, attenuated vaccines against flavivirus infections. Vaccine 2002, 20(7-8):1004-1018.
    • (2002) Vaccine , vol.20 , Issue.7-8 , pp. 1004-1018
    • Monath, T.P.1    McCarthy, K.2    Bedford, P.3    Johnson, C.T.4    Nichols, R.5    Yoksan, S.6
  • 18
    • 0141537467 scopus 로고    scopus 로고
    • Chimeric live, attenuated vaccine against Japanese encephalitis (ChimeriVax-JE): phase 2 clinical trials for safety and immunogenicity, effect of vaccine dose and schedule, and memory response to challenge with inactivated Japanese encephalitis antigen
    • Monath T.P., Guirakhoo F., Nichols R., Yoksan S., Schrader R., Murphy C., et al. Chimeric live, attenuated vaccine against Japanese encephalitis (ChimeriVax-JE): phase 2 clinical trials for safety and immunogenicity, effect of vaccine dose and schedule, and memory response to challenge with inactivated Japanese encephalitis antigen. J Infect Dis 2003, 188(8):1213-1230.
    • (2003) J Infect Dis , vol.188 , Issue.8 , pp. 1213-1230
    • Monath, T.P.1    Guirakhoo, F.2    Nichols, R.3    Yoksan, S.4    Schrader, R.5    Murphy, C.6
  • 19
    • 26644464588 scopus 로고    scopus 로고
    • Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004
    • Hombach J., Solomon T., Kurane I., Jacobson J., Wood D. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004. Vaccine 2005, 23(45):5205-5211.
    • (2005) Vaccine , vol.23 , Issue.45 , pp. 5205-5211
    • Hombach, J.1    Solomon, T.2    Kurane, I.3    Jacobson, J.4    Wood, D.5
  • 20
    • 4043092660 scopus 로고    scopus 로고
    • Arguments for live flavivirus vaccines
    • Hombach J., Kurane I., Wood D. Arguments for live flavivirus vaccines. Lancet 2004, 364(9433):498-499.
    • (2004) Lancet , vol.364 , Issue.9433 , pp. 498-499
    • Hombach, J.1    Kurane, I.2    Wood, D.3
  • 21
    • 71449111221 scopus 로고    scopus 로고
    • Preclinical and clinical development of YFV 17D-based chimeric vaccines against dengue, West Nile and Japanese encephalitis viruses
    • Guy B., Guirakhoo F., Barban V., Higgs S., Monath T.P., Lang J. Preclinical and clinical development of YFV 17D-based chimeric vaccines against dengue, West Nile and Japanese encephalitis viruses. Vaccine 2010, 28(3):632-649.
    • (2010) Vaccine , vol.28 , Issue.3 , pp. 632-649
    • Guy, B.1    Guirakhoo, F.2    Barban, V.3    Higgs, S.4    Monath, T.P.5    Lang, J.6
  • 22
    • 0034724358 scopus 로고    scopus 로고
    • Points to consider in the development of a surrogate for efficacy of novel Japanese encephalitis virus vaccines
    • Markoff L. Points to consider in the development of a surrogate for efficacy of novel Japanese encephalitis virus vaccines. Vaccine 2000, 18(Suppl. 2):26-32.
    • (2000) Vaccine , vol.18 , Issue.SUPPL. 2 , pp. 26-32
    • Markoff, L.1
  • 23
    • 0034724247 scopus 로고    scopus 로고
    • Phylogenetic analysis suggests only one serotype of Japanese encephalitis virus
    • Tsarev S.A., Sanders M.L., Vaughn D.W., Innis B.L. Phylogenetic analysis suggests only one serotype of Japanese encephalitis virus. Vaccine 2000, 18(Suppl. 2):36-43.
    • (2000) Vaccine , vol.18 , Issue.SUPPL. 2 , pp. 36-43
    • Tsarev, S.A.1    Sanders, M.L.2    Vaughn, D.W.3    Innis, B.L.4
  • 24
    • 0030896729 scopus 로고    scopus 로고
    • Antigenic and genetic variations among Japanese encephalitis virus strains belonging to genotype 1
    • Ali A., Igarashi A. Antigenic and genetic variations among Japanese encephalitis virus strains belonging to genotype 1. Microbiol Immunol 1997, 41(3):241-252.
    • (1997) Microbiol Immunol , vol.41 , Issue.3 , pp. 241-252
    • Ali, A.1    Igarashi, A.2
  • 25
    • 0027173831 scopus 로고
    • Immunogenicity of wild-type and vaccine strains of Japanese encephalitis virus and the effect of haplotype restriction on murine immune responses
    • Wills M.R., Singh B.K., Debnath N.C., Barrett A.D. Immunogenicity of wild-type and vaccine strains of Japanese encephalitis virus and the effect of haplotype restriction on murine immune responses. Vaccine 1993, 11(7):761-766.
    • (1993) Vaccine , vol.11 , Issue.7 , pp. 761-766
    • Wills, M.R.1    Singh, B.K.2    Debnath, N.C.3    Barrett, A.D.4
  • 26
    • 0026693564 scopus 로고
    • Antigenic characterization of the live attenuated Japanese encephalitis vaccine virus SA14-14-2: a comparison with isolates of the virus covering a wide geographic area
    • Wills M.R., Sil B.K., Cao J.X., Yu Y.X., Barrett A.D. Antigenic characterization of the live attenuated Japanese encephalitis vaccine virus SA14-14-2: a comparison with isolates of the virus covering a wide geographic area. Vaccine 1992, 10(12):861-872.
    • (1992) Vaccine , vol.10 , Issue.12 , pp. 861-872
    • Wills, M.R.1    Sil, B.K.2    Cao, J.X.3    Yu, Y.X.4    Barrett, A.D.5
  • 27
    • 0019842023 scopus 로고
    • Persistence of neutralizing antibody 30-35 years after immunization with 17D yellow fever vaccine
    • Poland J.D., Calisher C.H., Monath T.P., Downs W.G., Murphy K. Persistence of neutralizing antibody 30-35 years after immunization with 17D yellow fever vaccine. Bull World Health Organ 1981, 59:895-900.
    • (1981) Bull World Health Organ , vol.59 , pp. 895-900
    • Poland, J.D.1    Calisher, C.H.2    Monath, T.P.3    Downs, W.G.4    Murphy, K.5
  • 28
    • 33745237160 scopus 로고    scopus 로고
    • 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
    • Guirakhoo F., Kitchener S., Morrison D., Forrat R., McCarthy K., Nichols R., et al. 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 Vaccine 2006, 2(2):60-67.
    • (2006) Hum Vaccine , vol.2 , Issue.2 , pp. 60-67
    • Guirakhoo, F.1    Kitchener, S.2    Morrison, D.3    Forrat, R.4    McCarthy, K.5    Nichols, R.6
  • 29
    • 40549089216 scopus 로고    scopus 로고
    • Recombinant chimeric virus with wild-type dengue 4 virus premembrane and envelope and virulent yellow fever virus Asibi backbone sequences is dramatically attenuated in nonhuman primates
    • McGee C.E., Lewis M.G., Claire M.S., Wagner W., Lang J., Guy B., et al. Recombinant chimeric virus with wild-type dengue 4 virus premembrane and envelope and virulent yellow fever virus Asibi backbone sequences is dramatically attenuated in nonhuman primates. J Infect Dis 2008, 197(5):693-697.
    • (2008) J Infect Dis , vol.197 , Issue.5 , pp. 693-697
    • McGee, C.E.1    Lewis, M.G.2    Claire, M.S.3    Wagner, W.4    Lang, J.5    Guy, B.6
  • 30
    • 34548254907 scopus 로고    scopus 로고
    • Construction and biological characterization of artificial recombinants between a wild type flavivirus (Kunjin) and a live chimeric flavivirus vaccine (ChimeriVax-JE)
    • Pugachev K.V., Schwaiger J., Brown N., Zhang Z.X., Catalan J., Mitchell F.S., et al. Construction and biological characterization of artificial recombinants between a wild type flavivirus (Kunjin) and a live chimeric flavivirus vaccine (ChimeriVax-JE). Vaccine 2007, 25(37-38):6661-6671.
    • (2007) Vaccine , vol.25 , Issue.37-38 , pp. 6661-6671
    • Pugachev, K.V.1    Schwaiger, J.2    Brown, N.3    Zhang, Z.X.4    Catalan, J.5    Mitchell, F.S.6
  • 31
    • 78650416836 scopus 로고    scopus 로고
    • Safety and Immunogenicity of a Single Administration of Live-attenuated Japanese Encephalitis Vaccine in Previously Primed 2- to 5-year-olds and Naive 12- to 24-month-olds. Multicenter Randomized Controlled Trial
    • [Epub ahead of print. Sep 17]
    • Chokephaibulkit K., Sirivichayakul C., Thisyakorn U., Sabchareon A., Pancharoen C., Bouckenooghe A., Gailhardou S., Boaz M., Feroldi E. Safety and Immunogenicity of a Single Administration of Live-attenuated Japanese Encephalitis Vaccine in Previously Primed 2- to 5-year-olds and Naive 12- to 24-month-olds. Multicenter Randomized Controlled Trial. The Pediatric Infectious Disease Journal 2010, 29(12). [Epub ahead of print. Sep 17].
    • (2010) The Pediatric Infectious Disease Journal , vol.29 , Issue.12
    • Chokephaibulkit, K.1    Sirivichayakul, C.2    Thisyakorn, U.3    Sabchareon, A.4    Pancharoen, C.5    Bouckenooghe, A.6    Gailhardou, S.7    Boaz, M.8    Feroldi, E.9
  • 32
    • 48749089355 scopus 로고    scopus 로고
    • Randomised, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine
    • Tauber E., Kollaritsch H., von Sonnenburg F., Lademann M., Jilma B., Firbas C., et al. Randomised, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine. J Infect Dis 2008, 198(4):493-499.
    • (2008) J Infect Dis , vol.198 , Issue.4 , pp. 493-499
    • Tauber, E.1    Kollaritsch, H.2    von Sonnenburg, F.3    Lademann, M.4    Jilma, B.5    Firbas, C.6
  • 33
    • 0034469948 scopus 로고    scopus 로고
    • Growth characteristics of the chimeric Japanese encephalitis virus vaccine candidate, ChimeriVax-JE (YF/JE SA14-14-2), in Culex tritaeniorhynchus, Aedes albopictus, and Aedes aegypti mosquitoes
    • Bhatt T.R., Crabtree M.B., Guirakhoo F., Monath T.P., Miller B.R. Growth characteristics of the chimeric Japanese encephalitis virus vaccine candidate, ChimeriVax-JE (YF/JE SA14-14-2), in Culex tritaeniorhynchus, Aedes albopictus, and Aedes aegypti mosquitoes. Am J Trop Med Hyg 2000, 62(4):480-484.
    • (2000) Am J Trop Med Hyg , vol.62 , Issue.4 , pp. 480-484
    • Bhatt, T.R.1    Crabtree, M.B.2    Guirakhoo, F.3    Monath, T.P.4    Miller, B.R.5


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