Why the study?
The study evaluated the immunogenicity, safety, and interchangeability of a single-dose inactivated Vero-cell derived JENVAC compared to the live-attenuated SA 14-14-2 vaccine in healthy children.
Does a single dose of JENVAC improve immunogenicity compared to SA 14-14-2 in healthy children?
Does a single dose of JENVAC improve immunogenicity compared to SA 14-14-2 in healthy children?
A single dose of the inactivated JENVAC vaccine induces higher and persistent immune responses compared to the live-attenuated SA 14-14-2 vaccine in healthy children.
Supports JENVAC over SA 14-14-2 for pediatric JE vaccination; confirms superior immunogenicity of the inactivated vaccine in RCT.
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, multicenter, 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 2 years (day 720) postvaccination, 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 interchangeability study, children receiving 2 doses of JENVAC reported significantly higher response compared with 2 doses of SA 14-14-2. No difference in adverse events was observed. These corroborate with excellent seroprotection after the first dose of an earlier JENVAC study. CONCLUSIONS: A single-dose vaccination with JENVAC induces protective titers that persist up to 1 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 Japanese encephalitis vaccine.
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Vadrevu et al. (2019) studied this question.
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