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 Vaccines

Volumn 6, Issue 11, 2010, Pages 906-914

  Nasveld, Peter E ^a,b   Marjason, Joanne ^c   Bennett, Sonya ^a,b   Aaskov, John ^a,d   Elliott, Suzanne ^c   McCarthy, Karen ^e,g   Kanesa Thasan, Niranjan ^e,h   Feroldi, Emmanuel ^f   Reid, Mark ^a  

^a AUSTRALIAN ARMY MALARIA INSTITUTE   (Australia)

^b Center for Military and Veterans Health   (Australia)

^c Q Pharm   (Australia)

^d QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^e Acambis   (United States)

^f SANOFI PASTEUR   (France)

^g PPD Inc   (United Kingdom)

^h Novartis Vaccines and Diagnostics Inc   (United States)

Author keywords

Immunogenicity; Japanese encephalitis vaccine; Safety; Vaccine compatibility; Yellow fever vaccine

Indexed keywords

JAPANESE ENCEPHALITIS VACCINE; NEUTRALIZING ANTIBODY; PLACEBO; STAMARIL; UNCLASSIFIED DRUG; YELLOW FEVER VACCINE;

ABDOMINAL PAIN; ADULT; ANTIBODY TITER; ARTICLE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG DOSE COMPARISON; DRUG DOSE SEQUENCE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INJECTION SITE BLEEDING; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; JAPANESE ENCEPHALITIS; MAJOR CLINICAL STUDY; MALAISE; MALE; MEDIASTINUM DISEASE; MUSCULOSKELETAL DISEASE; MYALGIA; NAUSEA; NEUROLOGIC DISEASE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SEROCONVERSION; SORE THROAT; THORAX DISEASE; VIRUS NEUTRALIZATION; YELLOW FEVER;

ADOLESCENT; ADULT; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; DOUBLE-BLIND METHOD; ENCEPHALITIS, JAPANESE; FEMALE; HUMANS; JAPANESE ENCEPHALITIS VACCINES; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; PLACEBOS; PLAQUE ASSAY; VACCINATION; VACCINES, ATTENUATED; VACCINES, COMBINED; YELLOW FEVER; YELLOW FEVER VACCINE; YOUNG ADULT;

EID: 78649372673     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.6.11.12854     Document Type: Article

References (22)

1. Tsai TF, Yu XY. Japanese encephalitis vaccines. In: Plotkin SA, Mortimer EA, Eds. Vaccines. Second edition. Philadelphia, PA: WB Saunders 1994; 671-714.
2. Oya A. Japanese encephalitis vaccine. Act Pediatri Jpn 1998; 30:175-84.
3. Hoke CH, Nisalak A, Sangawhipa N, Jatanasen S, Laoraka-pongse T, Innis BL, et al. Protection against Japanese encephalitis by inactivated vaccines. N Engl J Med 1998; 319:608-14.
4. DeFraites RF, Gambel JM, Hoke CH Jr, Sanchez SL, Withers BG, Karabatsos N, et al. Japanese encephalitis vaccine (inactivated, biken) in US soldiers: immunogenicity and safety of vaccine in two dosing regimens. Am J Trop Med Hyg 1999; 61:288-93.
5. Gambel JM, DeFraites R, Hoke C, Brown A, Sanchez J, Karabatsos N, et al. Japanese encephalitis vaccine: persistence of antibody up to 3 years after a three-dose primary series. J Infect Dis 1995; 171:1074.
6. Tsai TF, Chang GJ, Yu YX. Japanese encephalitis vaccines. In: Plotkin SA, Orenstein WA, eds. Vaccines, third edition. Philadelphia, PA: WB Saunders 1999; 672-710.
7. Ruff TA, Eisen D, Fuller A, Kass R. Adverse reactions to Japanese encephalitis vaccine. Lancet 1991; 338:881-2.
8. Tsai TF. New initiatives for the control of Japanese encephalitis by vaccination: minutes of a WHO/CVI meeting Bangkok, Thailand 13-15 October 1998. Vaccine 2000; 18:1-25.
9. Nimmannitya S, Hutamai S, Kalayanarooj S, Rojanasuphot S. A field study on Nakayama and Beijing strains of Japanese encephalitis vaccines. Southeast Asian J Trop Med Public Health 1995; 26:689-93.
10. Chambers TJ, Nestorowicz A, Mason PW, Rice CM. Yellow fever/Japanese encephalitis chimeric viruses: construction and biological properties. J Virol 1999; 73:3095-101.
11. Monath TP, McCarthy K, Bedford P, Johnson CT, Nichols R, Yoksan S, et al. Clinical proof of principle for chimerivax: recombinant live, attenuated vaccines against flavivirus infections. Vaccine 2002; 20:1004-18. (Pubitemid 34135935)
12. Monath TP, 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; 188:1213-30. (Pubitemid 37338987)
13. Johnson C, Monath TP, Kanesa-thasan N, Mathis D, Miller C, Shapiro S, et al. Exercise-induced serum enzyme elevations confounding the evaluation of investigational drug toxicity. Report of two cases in a vaccine trial. Hum Vaccin 2005; 1:24-9.
14. Monath TP, Soike K, Levenbook I, Zhang ZX, 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-204 virus is safe, immunogenic and protective in non-human primates. Vaccine 1999; 17:1869-82.
15. Ku CC, King CC, Lin CY, Hsu HC, Chen LY, Yueh YY, et al. Homologous and heterologous neutralization of antibody responses after immunization with Japanese encephalitis vaccine among Taiwan children. J Med Virol 1994; 44:122-31.
16. th edition. Philadelphia, PA: Saunders Elsevier 2004; 311-52.
17. Hennessy S, Zhengie L, Tsai TF, Strom BL, Chao-Min W, Hui-Lian L, et al. Effectiveness of live-attenuated Japanese encephalitis vaccine (SA14-14-2): a case control study. Lancet 1996; 347:1583-6.
18. Bista MB, Banerjee MK, Shin SH, Tandan JB, Kim MH, Sohn YM, et al. Efficacy of a single-dose SA 14-14-2 vaccine against Japanese encephalitis: a case control study. Lancet 2001; 358:791-5.
19. Ohrr H, Tandan JB, Sohn YM, Shin SH, Pradhan DP, Halstead SB. 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; 366:1375-8.
20. Tandan JB, Ohrr H, Young MS, Yoksan S, Ji M, Nam CM, 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; 25:5041-5. (Pubitemid 46881266)
21. Beasley DWC, Li L, Suderman MT, Guirakhoo F, Trent DW, Monath TP, et al. Protection against Japanese encephalitis virus strains representing four genotypes by passive transfer of sera against ChimeriVax™-JE experimental vaccine. Vaccine 2004; 22:3722-6.
22. Russell PK, Nisalak A, Sukhavachana P, Vivona S. A plaque reduction test for dengue virus neutralizing antibodies. J Immunol 1967; 99:285-90.