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Title: Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials.
Austin Authors: Torresi, Joseph ;McCarthy, Karen;Feroldi, Emmanuel;Méric, Claude
Affiliation: Department of Infectious Diseases, Austin Hospital, Heidelberg, Victoria, Australia
Issue Date: 8-Oct-2010
Publication information: Vaccine 2010; 28(50): 7993-8000
Abstract: Japanese encephalitis chimeric virus vaccine (JE-CV) was developed to replace licensed mouse brain-derived vaccine (MBD-JE), the production of which ceased in 2005. Two randomised controlled phase 3 studies were conducted. Immunogenicity study: 410 participants received one JE-CV injection, 410 received 3 MBD-JE injections. Safety study: 1,601 participants received JE-CV, 403 received placebo. Seroconversion after a single JE-CV vaccination (99.1%) was statistically non-inferior to that after three-dose MBD-JE (95.1%) vaccination. JE-CV elicited a rapid immune response, with 93.6% of participants seroconverting within 14 days. Adverse reaction rates were significantly lower with JE-CV (67.6%) than with MBD-JE (82.2%) (p<0.001), and the reactogenicity profile of JE-CV was comparable with that of placebo. A single dose of JE-CV elicited rapid seroconversion in a higher proportion of vaccinees than the current vaccine with fewer reactions. The safety profile of JE-CV is good.
Gov't Doc #: 20934459
DOI: 10.1016/j.vaccine.2010.09.035
Type: Journal Article
Subjects: Adolescent
Aged, 80 and over
Antibodies, Neutralizing.blood
Antibodies, Viral.blood
Double-Blind Method
Encephalitis, Japanese.prevention & control
Japanese Encephalitis Vaccines.administration & dosage.adverse effects.immunology
Middle Aged
Neutralization Tests
Vaccines, Attenuated.administration & dosage.adverse effects.immunology
Young Adult
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