WHO working group on the quality, safety and efficacy of Japanese encephalitis vaccines (live attenuated) for human use, Bangkok, Thailand, 21-23 February 2012

Biologicals

Volumn 41, Issue 6, 2013, Pages 450-457

  Trent, Dennis W ^a   Minor, Philip ^b   Jivapaisarnpong, Teeranart ^c   Shin, Jinho ^d  

^a UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^b NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^c MINISTRY OF PUBLIC HEALTH   (Thailand)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Efficacy; Japanese encephalitis vaccine; Quality; Safety; World Health Organization

Indexed keywords

IMOJEVMD; JAPANESE ENCEPHALITIS VACCINE; MEASLES VACCINE; NEUTRALIZING ANTIBODY; THAIJEV; UNCLASSIFIED DRUG;

ADVERSE OUTCOME; CONFERENCE PAPER; DISEASE ACTIVITY; DRUG APPROVAL; DRUG EFFECT; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG USE; GENOTYPE; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFECTION CONTROL; JAPANESE ENCEPHALITIS; NONHUMAN; PRIORITY JOURNAL; SINGLE DRUG DOSE; THAILAND; UNSPECIFIED SIDE EFFECT; VACCINE PRODUCTION; VIRAL GENETICS; VIROGENESIS; VIRUS ATTENUATION; VIRUS TRANSMISSION;

JAPANESE ENCEPHALITIS VIRUS;

EFFICACY; JAPANESE ENCEPHALITIS VACCINE; QUALITY; SAFETY; WORLD HEALTH ORGANIZATION;

ENCEPHALITIS VIRUS, JAPANESE; ENCEPHALITIS, JAPANESE; HUMANS; JAPANESE ENCEPHALITIS VACCINES; PRACTICE GUIDELINES AS TOPIC; TREATMENT OUTCOME; VACCINATION; VACCINES, ATTENUATED; WORLD HEALTH ORGANIZATION;

EID: 84888005485     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2013.06.001     Document Type: Conference Paper

References (46)

1. Campbell G.L., Hills S.L., Fischer M., Jacobson J.A., Hoke C.H., Hombach J.M., et al. Estimated global incidence of Japanese encephalitis: a systematic review. Bulletin of the World Health Organization 2011, 89:766-774. 74A-E.
2. Halstead S.B., Jacobson J. Japanese encephalitis vaccines. Vaccines 2008, 311-352. Elsevier. 5th ed. S.A. Plotkin, W.A. Orenstein, P.A. Offit (Eds.).
3. Solomon T. Control of Japanese encephalitis-within our grasp?. The New England Journal of Medicine 2006, 355:869-871.
4. Halstead S.B., Thomas S.J. New Japanese encephalitis vaccines: alternatives to production in mouse brain. Expert Review of Vaccines 2011, 10:355-364.
5. Takahashi H., Pool V., Tsai T.F., Chen R.T. Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States. The VAERS Working Group. Vaccine 2000, 18:2963-2969.
6. Ferguson M., Kurane I., Wimalaratne O., Shin J., Wood D. WHO informal consultation on the scientific basis of specifications for production and control of inactivated Japanese encephalitis vaccines for human use, Geneva, Switzerland, 1-2 June 2006. Vaccine 2007, 25:5233-5243.
7. Recommendations for Japanese encephalitis vaccine (inactivated) for human use (Revised 2007) 2011, WHO Expert Committee on Biological Standardization, World Health Organization, Geneva.
8. Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use 2002, WHO Expert Committee on Biological Standardization, World Health Organization, Geneva.
9. Burke D.S., Monath T.P. Flaviviruses. Virology 2001, 1043-1126. Lippincott Williams & Wilkins, Philadelphia. D. Knipe, H. PM (Eds.).
10. Liu X., Yu Y., Li M., Liang G., Wang H., Jia L., et al. Study on the protective efficacy of SA14-14-2 attenuated Japanese encephalitis against different JE virus isolates circulating in China. Vaccine 2011, 29:2127-2130.
11. 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. Journal of Virology 2000, 74:1742-1751.
12. Monath T.P., Myers G.A., Beck R.A., Knauber M., Scappaticci K., Pullano T., et al. Safety testing for neurovirulence of novel live, attenuated flavivirus vaccines: infant mice provide an accurate surrogate for the test in monkeys. Biologicals: Journal of the International Association of Biological Standardization 2005, 33:131-144.
13. Staples J.E., Gershman M., Fischer M., Centers for Disease C Prevention Yellow fever vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports: Morbidity and Mortality Weekly Report Recommendations and reports/Centers for Disease Control 2010, 59:1-27.
14. Arroyo J., Guirakhoo F., Fenner S., Zhang Z.X., Monath T.P., Chambers T.J. Molecular basis for attenuation of neurovirulence of a yellow fever Virus/Japanese encephalitis virus chimera vaccine (ChimeriVax-JE). Journal of Virology 2001, 75:934-942.
15. Schuh A.J., Li L., Tesh R.B., Innis B.L., Barrett A.D. Genetic characterization of early isolates of Japanese encephalitis virus: genotype II has been circulating since at least 1951. The Journal of General Virology 2010, 91:95-102.
16. Solomon T., Ni H., Beasley D.W., Ekkelenkamp M., Cardosa M.J., Barrett A.D. Origin and evolution of Japanese encephalitis virus in southeast Asia. Journal of Virology 2003, 77:3091-3098.
17. Takhampunya R., Kim H.C., Tippayachai B., Kengluecha A., Klein T.A., Lee W.J., et al. Emergence of Japanese encephalitis virus genotype V in the Republic of Korea. Virology Journal 2011, 8:449.
18. Wang H.Y., Takasaki T., Fu S.H., Sun X.H., Zhang H.L., Wang Z.X., et al. Molecular epidemiological analysis of Japanese encephalitis virus in China. The Journal of General Virology 2007, 88:885-894.
19. Wang L., Fu S., Zhang H., Ye X., Yu D., Deng Z., et al. Identification and isolation of Genotype-I Japanese encephalitis virus from encephalitis patients. Virology Journal 2010, 7:345.
20. Pan X.L., Liu H., Wang H.Y., Fu S.H., Liu H.Z., Zhang H.L., et al. Emergence of genotype I of Japanese encephalitis virus as the dominant genotype in Asia. Journal of Virology 2011, 85:9847-9853.
21. Yu Y. Phenotypic and genotypic characteristics of Japanese encephalitis attenuated live vaccine virus SA14-14-2 and their stabilities. Vaccine 2010, 28:3635-3641.
22. 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, 257:363-372.
23. Chambers T.J., Nestorowicz A., Mason P.W., Rice C.M. Yellow fever/Japanese encephalitis chimeric viruses: construction and biological properties. Journal of Virology 1999, 73:3095-3101.
24. 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, 22:3722-3726.
25. 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. The American Journal of Tropical Medicine and Hygiene 2000, 62:480-484.
26. Reid M., Mackenzie D., Baron A., Lehmann N., Lowry K., Aaskov J., et al. Experimental infection of Culex annulirostris, Culex gelidus, and Aedes vigilax with a yellow fever/Japanese encephalitis virus vaccine chimera (ChimeriVax-JE). The American Journal of Tropical Medicine and Hygiene 2006, 75:659-663.
27. Zhang Y., Zhang H., Yu Y., Feng Y., Dong G., Yang W.H., et al. Studies on Culex tritaeniorhynchus and Culex pipiens quinquefascitatus infected orally by Japanese encephalitis SA14-14-2 vaccine virus. Chinese Journal of Zoonoses 2005, 21:584-586.
28. Liu Z.-E., Yu Y.-I., Zhang H.-L. Biological and molecular characteristics of live attenuated Japanese encephalitis vaccine viru strain SA14-14-2 inoculated intrathoracically to Culex tritaniorhynchus. China Journal of Biology 2007, 20:419-421.
29. Zhang Y.Z., Zhang H.L., Yu Y.X., Feng Y., Dong G.M., Yang W.H., et al. Research on Culex tritaeniorhynchus and Culex pipiens quinquefasciatus intrathoracically infected with attenuated Japanese encephalitis virus SA14-14-2 vaccine strain. Chinese Journal of Experimental and Clinical Virology 2005, 19:344-346.
30. Feng Y., Zhang H.-I., Yu Y.-I. Observations on the replication of virus and stability of virulence in Culex tritaeniorhynchus after intrathoracically inoculation with attenuated Japanese encephalitis virus SA14-14-2 vaccine strain. Chinese Journal of Zoonoses 2007, 23:279-281.
31. Sohn Y.M., Tandan J.B., Yoksan S., Ji M., Ohrr H. A5-year follow-up of antibody response in children vaccinated with single dose of live attenuated SA14-14-2 Japanese encephalitis vaccine: immunogenicity and anamnestic responses. Vaccine 2008, 26:1638-1643.
32. Ohrr H., Tandan J.B., Sohn Y.M., Shin S.H., Pradhan D.P., Halstead S.B. Effect of single dose of SA 14-14-2 vaccine 1 year after immunisation in Nepalese children with Japanese encephalitis: a case-control study. Lancet 2005, 366:1375-1378.
33. Tandan J.B., Ohrr H., Sohn Y.M., Yoksan S., Ji M., Nam C.M., et al. Single dose of SA 14-14-2 vaccine provides long-term protection against Japanese encephalitis: a case-control study in Nepalese children 5 years after immunization. Vaccine 2007, 25:5041-5045.
34. Global Advisory Committee on Vaccine Safety, 9-10 June 2005. Weekly Epidemiological Record 2005, 80:242-246.
35. Guidelines on the quality, safety and efficacy of dengue vaccines (live, tetravalent) (adopted, 2011). WHO Expert Committee on Biological Standardization. Geneva: World Health Organization.
36. Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines (adopted, 2010). WHO Expert Committee on Biological Standardization. Geneva: World Health Organization. http://www.who.int/biologicals/vaccines/yellow_fever/en/index.html.
37. Monath T.P., Arroyo J., Levenbook I., Zhang Z.X., Catalan J., Draper K., et al. Single mutation in the flavivirus envelope protein hinge region increases neurovirulence for mice and monkeys but decreases viscerotropism for monkeys: relevance to development and safety testing of live, attenuated vaccines. Journal of Virology 2002, 76:1932-1943.
38. 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, 17:1869-1882.
39. Chokephaibulkit K., Sirivichayakul C., Thisyakorn U., Sabchareon A., Pancharoen C., Bouckenooghe A., et al. 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, 29:1111-1117.
40. Desai K., Coudeville L., Bailleux F. Modelling the long-term persistence of neutralizing antibody in adults after one dose of live attenuated Japanese encephalitis chimeric virus vaccine. Vaccine 2012, 30:2510-2515.
41. Feroldi E., Capeding M.R., Boaz M., Gailhardou S., Meric C., Bouckenooghe A. Memory immune response and safety of a booster dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in JE-CV-primed children. Human Vaccines & Immunotherapeutics 2013, 9.
42. Feroldi E., Pancharoen C., Kosalaraksa P., Watanaveeradej V., Phirangkul K., Capeding M.R., et al. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Human Vaccines & Immunotherapeutics 2012, 8:929-937.
43. 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. The Journal of Infectious Diseases 2003, 188:1213-1230.
44. 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, 20:1004-1018.
45. Nasveld P.E., Marjason J., Bennett S., Aaskov J., Elliott S., McCarthy K., et al. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Human Vaccine 2010, 6:906-914.
46. Torresi J., McCarthy K., Feroldi E., Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: randomised controlled phase 3 trials. Vaccine 2010, 28:7993-8000.