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Persistence of Immune responses with an Inactivated Japanese Encephalitis single-dose vaccine JENVAC® and interchangeability with a live-attenuated vaccine.


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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Persistence of Immune Responses With an Inactivated Japanese Encephalitis Single-Dose Vaccine, JENVAC and Interchangeability With a Live-Attenuated Vaccine.

Vadrevu Krishna Mohan KM   Potula Venugopal V   Khalatkar Vasant V   Mahantshetty Niranjana S NS   Shah Atish A   Ella Raches R  

The Journal of infectious diseases 20201001 9


<h4>Background</h4>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.<h4>Methods</h4>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  ...[more]

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