Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO®, IC51
Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO®, IC51
复制标题
DOI：
10.1016/j.vaccine.2011.01.058
复制
发表时间：
2011-03-21
期刊：
影响因子：
5.5
通讯作者：
Klade, Christoph S.
中科院分区：
文献类型：
--
作者：
Eder, Susanne;Dubischar-Kastner, Katrin;Klade, Christoph S.
简介：IXIARO（IC 51）是最近批准的日本灭活疫苗，在0/28天初次免疫计划中具有免疫原性和安全性。中和抗体滴度下降，随着时间的推移和加强剂量可能需要提高持久性immunity.Objectives：为了评估效果的加强剂量对中和乙脑抗体滴度长达12个月后boosting.Methods：在这个第三阶段的试验，198名受试者，谁接受了初级免疫接种在前面的随机试验，加强与IXIARO 15个月后的初级免疫接种。中和抗体滴度进行了评估空斑减少中和试验，PRNT.Results：前加强剂量，69.2%（137/198）的受试者PRNT 50滴度≥ 1：10。加强免疫后1个月，PRNT 50>= 1：10（被认为是保护性滴度）的受试者比例为100%。这一比率在6个月和12个月时仍高达98.5%; GMT在加强前为22.5，在加强后1个月、6个月和12个月分别为900.487和361。初次免疫后15个月的IXIARO加强剂量具有高度免疫原性，GMT比初次免疫后立即观察到的GMT高>5倍，并在助推器后至少12个月保持在高水平。NCT 00595309。(C)2011爱思唯尔有限公司版权所有。
Introduction: IXIARO (IC51), a recently approved inactivated Japanese Encephalitis vaccine, is immunogenic and safe in a 0/28 days primary immunization schedule. Neutralizing antibody titers decline with time and booster doses are likely needed to enhance persistence of immunity.Objectives: To assess the effect of a booster dose on neutralizing JE antibody titers for up to 12 months after boostering.Methods: In this phase III trial, 198 subjects, who had received primary immunization in a preceding randomized trial, were boosted with IXIARO 15 months after the primary immunization. Neutralizing antibody titers were assessed by plaque-reduction neutralisation test, PRNT.Results: Prior to the booster dose, 69.2% (137/198) of subjects had PRNT50 titers >= 1:10. One month after the booster, the rate of subjects with PRNT50 >= 1:10 (recognized as a protective titer) was 100%. This rate remained high at 98.5% at 6 and 12 months; GMTs were 22.5 before the booster and 900.487 and 361 at 1, 6 and 12 months after the booster, respectively.Conclusion: A booster dose of IXIARO at 15 months after primary immunization was highly immunogenic with GMTs >5-fold higher than those seen immediately after primary immunization, and remained at high levels for at least 12 months after the booster. NCT00595309. (C) 2011 Elsevier Ltd. All rights reserved.