Bonaparte Matthew, Dweik Bashir, Feroldi Emmanuel, Meric Claude, Bouckenooghe Alain, Hildreth Stephen, Hu Branda, Yoksan Sutee, Boaz Mark
Sanofi Pasteur Global Clinical Immunology Department, Swiftwater, USA.
BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.
During clinical development of the licensed Japanese encephalitis chimeric virus vaccine (JE-CV), the neutralization capacity of vaccine-induced antibodies was assessed against the vaccine virus and against well characterized wild-type (wt) viruses isolated between 1949-1991. We assessed whether JE-CV-induced antibodies can also neutralize more recent wt Japanese encephalitis virus (JEV) isolates including a genotype 1 isolate.
Sera from 12-18 month-old children who received a single dose of JE-CV in a phase III study in Thailand and the Philippines (ClinicalTrials.gov NCT00735644) were randomly selected and pooled according to neutralization titer against JE-CV into eight samples. Neutralization was assessed by plaque reduction neutralization tests (PRNT50) against three recent isolates from JEV genotypes 1 and 3 in addition to four JEV previously tested.
Neutralization titers against the three recent JEV strains were comparable to those observed previously against other strains and the vaccine virus. The observed differences between responses to genotype 1 and 3 viruses were within assay variability for the PRNT50.
The results were consistent with previously generated data on the neutralization of wt JEV isolates, immune responses induced by JE-CV neutralize recently isolated virus from southeast (SE) Asia and India.
在已获许可的日本脑炎嵌合病毒疫苗(JE-CV)的临床开发过程中,评估了疫苗诱导抗体对疫苗病毒以及对1949年至1991年间分离出的特征明确的野生型(wt)病毒的中和能力。我们评估了JE-CV诱导的抗体是否也能中和包括1型基因型分离株在内的更新的野生型日本脑炎病毒(JEV)分离株。
在泰国和菲律宾进行的一项III期研究(ClinicalTrials.gov NCT00735644)中,随机选择接受单剂量JE-CV的12至18个月大儿童的血清,并根据针对JE-CV的中和效价将其合并为八个样本。除了之前测试的四种JEV外,通过空斑减少中和试验(PRNT50)评估针对JEV 1型和3型的三种最新分离株的中和作用。
针对三种最新JEV毒株的中和效价与之前针对其他毒株和疫苗病毒观察到的效价相当。观察到的对1型和3型病毒反应之间的差异在PRNT50的测定变异性范围内。
结果与之前关于野生型JEV分离株中和作用的数据一致,JE-CV诱导的免疫反应能中和来自东南亚(SE)和印度的最近分离出的病毒。