基于TLR3受体激动剂的pika佐剂可加速狂犬病疫苗免疫应答

hantavirus · 发表于 2017-5-1 06:51:43

近日，疫苗学业内国际著名期刊“Vaccine”刊发皮卡人用狂犬病疫苗临床试验文章，结果显示基于TLR3受体激动剂的pika佐剂可加速狂犬病疫苗免疫应答并具较高安全性，简介如下。

背景介绍：狂犬病是由狂犬病病毒感染引起的致命的疾病，一旦发病，100%死亡，因此其中暴露后预防（PEP）在预防感染中至关重要。然而，目前大量临床病例显示，即使经过适当的PEP治疗，依然有死亡病例出现。除了暴露后处置不当的原因为，另一个主要原因则为疫苗免疫后未能及时产生有效抗体，PIKA佐剂狂犬病疫苗作为TLR3激动剂可以激活B淋巴细胞和T淋巴细胞，可刺激机体快速产生的较强的免疫应答。

方法：本文对健康成年人进行了I期，开放标签随机研究，以评估PIKA狂犬病疫苗的安全性和免疫原性，并增设加速疫苗免疫程序。将37例受试者随机分为3组：对照疫苗（诺华公司的人用狂犬病疫苗）经典程序；PIKA疫苗经典程序和PIKA疫苗加速程序。随访对象接受安全性，并检测狂犬病病毒中和抗体（RVNA）和T细胞应答检测。

结果：对照和PIKA狂犬病疫苗均耐受性良好。所有不良事件（AE）均为轻度和局部的。 PIKA加速免疫程序中中75％的受试者在第7天即抗体阳转（滴度不低于0.5IU / mL），而PIKA经典程序53.9％阳转（p = 0.411），而对照疫苗经典方案为16.7％（p = 0.012）。 PIKA狂犬病疫苗在疫苗接种后第7天引起病毒特异性CD4 T细胞应答，有效中和抗体滴度可维持42天。

PIKA狂犬病疫苗与健康成年人的市售疫苗相比具有良好的耐受性和更高的免疫原性。

原文信息：

Title：

An accelerated rabies vaccine schedule based on toll-like receptor 3(TLR3) agonist PIKA adjuvant augments rabies virus specific antibody and T cell response in healthy adult volunteers

Abstract:

Background: Rabies is a fatal disease where post-exposure prophylaxis (PEP) is crucial in preventing infection. However, deaths even after appropriate PEP, have been reported. The PIKA Rabies vaccine adjuvant is a TLR3 agonist that activates B and T cells leading to a robust immune response.
Methods: We conducted a phase I, open label, randomized study in healthy adults to assess the safety and immunogenicity of the PIKA Rabies vaccine and an accelerated vaccine regimen. Thirty-seven subjects were randomized into 3 groups: control vaccine classic regimen, PIKA vaccine classic regimen and PIKA vaccine accelerated regimen. Subjects were followed up for safety, rabies virus neutralizing antibodies (RVNA) and T cell responses.
Results: Both the control and PIKA Rabies vaccine were well tolerated. All adverse events (AEs) were mild and self-limiting. Seventy-five percent of subjects in the PIKA accelerated regimen achieved a RVNA titer P0.5 IU/mL on day 7, compared to 53.9% in the PIKA classic regimen (p = 0.411) and 16.7% in control vaccine classic regimen (p = 0.012). The PIKA rabies vaccine elicited multi-specific rabies CD4 mediated T cell response already detectable ex vivo at day 7 after vaccination and that was maintained at day 42.
Conclusion: The investigational PIKA rabies vaccine was well tolerated and more immunogenic than the commercially available vaccine in healthy adults.

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序道 · 发表于 2017-5-1 15:33:33

PIKA疫苗经典程序和PIKA疫苗加速程序区别有多大啊

hantavirus · 发表于 2017-5-1 06:53:37

文献全文如下：

wijaya2017.pdf (1.31 MB, 下载次数: 512)

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