Publication: Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: Randomized, double-blind, 5-year phase II study in healthy adults
Issued Date
2010-12-01
Resource Type
ISSN
15548619
15548600
15548600
Other identifier(s)
2-s2.0-78751677635
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Mahidol University
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SCOPUS
Bibliographic Citation
Human Vaccines. Vol.6, No.12 (2010), 1038-1046
Suggested Citation
Peter E. Nasveld, Andrew Ebringer, Nathan Elmes, Sonya Bennett, Sutee Yoksan, John Aaskov, Karen McCarthy, Niranjan Kanesa-thasan, Claude Meric, Mark Reid Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: Randomized, double-blind, 5-year phase II study in healthy adults. Human Vaccines. Vol.6, No.12 (2010), 1038-1046. doi:10.4161/hv.6.12.13057 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/29170
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Title
Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: Randomized, double-blind, 5-year phase II study in healthy adults
Abstract
In a randomized, double-blind study, 202 healthy adults were randomized to receive a live, attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) and placebo 28 days apart in a cross-over design. A subgroup of 98 volunteers received a JE-CV booster at month 6. Safety, immunogenicity and persistence of antibodies to month 60 were evaluated. There were no unexpected adverse events (AEs) and the incidence of AEs between JE-CV and placebo were similar. There were three serious adverse events (SAE ) and no deaths. A moderately severe case of acute viral illness commencing 39 days after placebo administration was the only SAE considered possibly related to immunization. 99% of vaccine recipients achieved a seroprotective antibody titer ≥10 to JE-CV 28 days following the single dose of JE-CV and 97% were seroprotected at month 6. Kaplan Meier analysis showed that after a single dose of JE-CV, 87% of the participants who were seroprotected at month 6 were still protected at month 60. This rate was 96% among those who received a booster immunization at month 6. 95% of subjects developed a neutralizing titer ≥10 against at least three of the four strains of a panel of wild-type Japanese encephalitis virus (JEV) strains on day 28 after immunization. At month 60, that proportion was 65% for participants who received a single dose of JE-CV and 75% for the booster group. These results suggest that JE-CV is safe, well tolerated and that a single dose provides long-lasting immunity to wild-type strains. © 2010 Landes Bioscience.