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Persistence of Immune responses with an Inactivated Japanese Encephalitis single-dose vaccine JENVAC® and interchangeability with a live-attenuated vaccine.
The Journal of Infectious Diseases ( IF 6.4 ) Pub Date : 2019-12-20 , DOI: 10.1093/infdis/jiz672
Krishna Mohan Vadrevu 1 , Venugopal Potula 2 , Vasant Khalatkar 3 , Niranjana S Mahantshetty 4 , Atish Shah 5 , Raches Ella 1
Affiliation  

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).

中文翻译:

灭活的日本脑炎单剂量疫苗JENVAC®的免疫应答持续存在,并且与减毒活疫苗具有互换性。

背景技术这项研究报告了健康儿童单剂量灭活的Vero细胞衍生的JENVAC®对减毒活SA 14-14-2疫苗的免疫原性,安全性和互换性。方法该4期,多中心,开放标签,随机对照试验招募了360名儿童,他们均被随机分配接受单剂量JENVAC®或SA 14-14-2的治疗。在不同的时间点对孩子进行跟踪,直到接种后两年(第720天),然后将每个组的一部分进行分组,并分配给他们加强剂量或其他疫苗。结果在所有时间点,JENVAC®组的免疫学指标均在统计学上较高。在可互换性研究中,与两剂SA 14-14-2相比,接受两剂JENVAC®的儿童的反应显着更高。没有观察到不良事件的差异。在较早的JENVAC®研究的第一剂量后,这些物质就具有出色的血清保护作用。结论用JENVAC®进行单剂量疫苗接种可产生保护性滴度,可持续长达一年。我们报告两种疫苗之间具有明显的互换性,其中JENVAC®/JENVAC®组合表现出最高的免疫反应。JENVAC®现在已被许可作为单剂量JE疫苗。临床试验注册(CTRI / 2014/02/004386和CTRI / 2016/05/006909)。与JENVAC®/JENVAC®组合使用时表现出最高的免疫反应。JENVAC®现在已被许可作为单剂量JE疫苗。临床试验注册(CTRI / 2014/02/004386和CTRI / 2016/05/006909)。与JENVAC®/JENVAC®组合使用具有最高的免疫反应。JENVAC®现在已被许可作为单剂量JE疫苗。临床试验注册(CTRI / 2014/02/004386和CTRI / 2016/05/006909)。
更新日期:2019-12-20
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