一项多中心、随机、对照、2/3期研究,旨在评估日本脑炎灭活疫苗在健康≥1至<3岁印度儿童中的安全性和免疫原性

S. Thuluva, K. Turaga, S. G. V., Rammohan Reddy M., V. Yerroju, P. Suneetha, Ramesh V. Matur
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摘要

背景:日本脑炎(JE)在印度各地流行。由于可用的治疗方案有限,人们高度期待一种安全有效的新治疗方案,以满足现有的医疗需求。方法:在目前的随机2/3期研究中,对456名健康≥1至3岁儿童进行了生物E (BE-JE)生产的2剂乙脑疫苗(BE-JE)的安全性、免疫原性和反应原性的评估,并与green -cross公司生产的3剂乙脑疫苗(gc - je)进行了比较。结果:在第56天,BE-JE组与GCC-JE组相比无劣效性,组间差异的下限不≥10%。在第56天,BE-JE组的几何平均滴度值显著高于GCC -JE组(217.97 vs 125.85;p = 0.0023)。两组疫苗的安全性无明显差异,报告的所有事件强度均为轻度或中度。此外,两组之间经历至少一次不良事件(AE)的受试者数量无显著差异(p=0.2198)。结论:目前的研究表明,在印度儿童人群中,与GCC - JE疫苗(3剂)相比,BE - JE基于vero细胞的灭活疫苗(2剂)具有免疫原性、良好的耐受性和非劣性。本研究已于2011年2月14日在印度临床试验注册中心前瞻性注册,编号为CTRI/2011/091/000108。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A multi-center, randomized, controlled, phase-2/3 study to evaluate the safety and immunogenicity of inactivated Japanese encephalitis vaccine in healthy ≥1 to <3 years old Indian children
Background: Japanese encephalitis (JE) is endemic in various parts of India. Due to the limited treatment options available, a new treatment option that is safe and effective is highly expected for the existing medical needs. Methods: In the present randomized Phase-2/3 study, safety, immunogenicity, and reactogenicity of JE-vaccine manufactured by Biological E (BE-JE), given in 2-dose schedule, 28-days apart was assessed in 456 healthy ≥1 to <3-year-old children compared to a licensed JE-vaccine with 3-dose schedule manufactured by Green-cross-corporation (GCC-JE). Results: The BE-JE group demonstrated non‑inferiority compared to GCC-JE group at day-56 as the lower confidence limit of the group difference was not ≥‑10%. At day-56, the geometric mean titre values were significantly higher in BE-JE group compared with the GCC‑JE group (217.97 vs 125.85; p=0.0023). No apparent difference was seen in the safety-profile between both vaccine groups, with all events reported being either mild or moderate in intensity. Also, no significant difference (p=0.2198) was reported in the number of subjects experiencing at least one adverse-event (AE) between both groups. Conclusions: The present study demonstrated BE‑JE’s Vero-cell‑based inactivated JE-vaccine, administered in 2-dose schedule to be immunogenic, well-tolerated, and non-inferior, compared to GCC‑JE-vaccine, administered in a 3‑dose schedule in the pediatric Indian-population. This study was prospectively registered with clinical trial registry of India bearing no CTRI/2011/091/000108 on 14/02/2011.
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