Persistence of Immune responses with an Inactivated Japanese Encephalitis single-dose vaccine JENVAC® and interchangeability with a live-attenuated vaccine.
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ABSTRACT: BACKGROUND:This study reports immunogenicity, safety and interchangeability of a single dose, inactivated Vero-cell derived, JENVAC® to the live attenuated SA 14-14-2 vaccine in healthy children. METHODS:This phase 4, multicentre, open-label, randomized control trial enrolled 360 children who were equally randomized to receive a single dose of either JENVAC® or SA 14-14-2. Children were followed at various time points, until two years (day 720) post-vaccination, upon which a subset from each group was divided and allocated to a receive a booster dose or the other vaccine. RESULTS:At all time points, immunological measures were statistically higher in the JENVAC® group. In the inter-changeability study, children receiving two doses of JENVAC® reported significantly higher response compared to two doses of SA 14-14-2. No difference in adverse events was observed. These corroborate with excellent seroprotection post the first dose of an earlier JENVAC® study. CONCLUSIONS:A single dose vaccination with JENVAC® induces protective titres that persist up to one year. We report appreciable interchangeability between both vaccines, with JENVAC®/JENVAC® combination exhibiting the highest immune response. JENVAC® is now licensed as a single dose JE vaccine. CLINICAL TRIALS REGISTRATION:(CTRI/2014/02/004386 and CTRI/2016/05/006909).
SUBMITTER: Vadrevu KM
PROVIDER: S-EPMC7529014 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
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