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Title: Immunogenicity of live attenuated Japanese encephalitis SA 14-14-2 vaccine among Sri Lankan children with previous receipt of inactivated JE vaccine
Authors: Pushpa Ranjan Wijesinghe
M. R.Nihal Abeysinghe
Sutee Yoksan
Yafu Yao
Benli Zhou
Lei Zhang
Jessica A. Fleming
Anthony A. Marfin
John C. Victor
Ministry of Health Colombo
Mahidol University
Chengdu Institute of Biological Products
PATH Seattle
Keywords: Biochemistry, Genetics and Molecular Biology;Immunology and Microbiology;Medicine
Issue Date: 21-Nov-2016
Citation: Vaccine. Vol.34, No.48 (2016), 5923-5928
Abstract: © 2016 The Author(s) Background The performance of live attenuated Japanese Encephalitis SA 14-14-2 vaccine (CD-JEV) among children previously given inactivated mouse brain-derived JE vaccine (IMBV) is unknown. We evaluated the safety and immunogenicity of CD-JEV administered to 2- and 5-year-old children in Sri Lanka. Methods In this open-label, single arm trial in the Colombo District of Sri Lanka, generally healthy children 2 and 5 years of age who had previously received two and three doses of IMBV, respectively, were administered one dose of CD-JEV subcutaneously. Participants were monitored for adverse events for one year post-vaccination. Serum neutralizing antibody responses were evaluated pre and 28 and 365 days post-vaccination using JE plaque reduction neutralization test and characterized as the proportion of participants seroconverting. Seroconversion was defined as either reaching a titer considered seroprotective (⩾1:10) among participants with a baseline titer <1:10 or achieving at least a 4-fold rise in titer among participants with a baseline titer ⩾1:10. Results Of 305 children given CD-JEV, 294 were included in the primary analysis of immunogenicity. Prior to vaccination, 144/147 (98.0%) 2-year-olds and 146/147 (99.3%) 5-year-olds had seroprotective levels. 28 days post-vaccination, 79/147 [53.7% (95% CI, 45.3–62.0)] 2-year olds and of 60/147 [40.8% (95% CI, 32.8–49.2)] 5-year olds achieved seroconversion. Among 2-year-olds, geometric mean titers (GMTs) rose from 697 to 3175 28 days post-vaccination. Among 5-year-olds, GMTs rose from 926 to 2776. Most adverse reactions were mild, and no serious adverse events were related to study vaccination. Conclusion Administration of CD-JEV to these children with pre-existing neutralizing JE antibody titers was safe and resulted in substantial boosting of antibody levels. These results may inform other countries in Asia considering switching from IMBV to now WHO-prequalified CD-JEV vaccine to combat this disease of public health importance.
ISSN: 18732518
Appears in Collections:Scopus 2016-2017

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