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首页> 外文期刊>Infection and immunity >Safety and Enhanced Immunogenicity of a Hepatitis B Core Particle Plasmodium falciparum Malaria Vaccine Formulated in Adjuvant Montanide ISA 720 in a Phase I Trial
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Safety and Enhanced Immunogenicity of a Hepatitis B Core Particle Plasmodium falciparum Malaria Vaccine Formulated in Adjuvant Montanide ISA 720 in a Phase I Trial

机译：在第一阶段试验中，在Montanide ISA 720佐剂中配制的乙型肝炎核心颗粒恶性疟原虫疟疾疫苗的安全性和增强的免疫原性

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Highly purified subunit vaccines require potent adjuvants in order to elicit optimal immune responses. In a previous phase I trial, an alum formulation of ICC-1132, a malaria vaccine candidate comprising hepatitis B core (HBc) virus-like particle containing Plasmodium falciparum circumsporozoite (CS) protein epitopes, was shown to elicit Plasmodium falciparum-specific antibody and cellular responses. The present study was designed as a single-blind, escalating-dose phase I trial to evaluate the safety and immunogenicity of single intramuscular doses of ICC-1132 formulated in the more potent water-in-oil adjuvant Montanide ISA 720 (ICC-1132/ISA 720). The vaccine was safe and well tolerated, with transient injection site pain as the most frequent complaint. All vaccinees that received either 20 μg or 50 μg of ICC-1132/ISA 720 developed antiimmunogen and anti-HBc antibodies. The majority of volunteers in these two groups developed sporozoite-specific antibodies, predominantly of opsonizing immunoglobulin G subtypes. Peak titers and persistence of parasite-specific antibody following a single injection of the ISA 720 formulated vaccine were comparable to those obtained following two to three immunizations with alum-adsorbed ICC-1132. Peripheral blood mononuclear cells of ICC-1132/ISA 720 vaccinees proliferated and released cytokines (interleukin 2 and gamma interferon) when stimulated with recombinant P. falciparum CS protein, and CS-specific CD4+ T-cell lines were established from volunteers with high levels of antibodies to the repeat region. The promising results obtained with a single dose of ICC-1132 formulated in Montanide ISA 720 encourage further clinical development of this malaria vaccine candidate.
机译：高度纯化的亚单位疫苗需要有效的佐剂才能引发最佳的免疫反应。在之前的第一阶段试验中，显示了一种ICC-1132的明矾制剂，它是一种包含B型肝炎核心（HBc）病毒样颗粒的疟疾疫苗候选物，该颗粒包含恶性疟原虫Circumsporozoite（CS）蛋白表位。诱导恶性疟原虫特异性抗体和细胞应答。本研究设计为单盲，剂量递增的I期临床试验，旨在评估在更有效的油包水佐剂Montanide ISA 720（ICC-1132 /中，以肌内注射的单剂量ICC-1132的安全性和免疫原性ISA 720）。该疫苗安全且耐受良好，最常见的症状是短暂的注射部位疼痛。接受20μg或50μgICC-1132 / ISA 720的所有疫苗均产生抗免疫原和抗HBc抗体。这两组中的大多数志愿者开发了子孢子特异性抗体，主要是调理免疫球蛋白G亚型。单次注射ISA 720配制的疫苗后的峰值滴度和持久性与持久性与用明矾吸附的ICC-1132进行2到3次免疫接种后获得的峰滴度和持久性相当。当用重组Pem刺激时，ICC-1132 / ISA 720疫苗的外周血单核细胞增殖并释放细胞因子（白介素2和γ干扰素）。从对重复区具有高水平抗体的志愿者建立了恶性疟原虫CS蛋白和CS特异性CD4 + T细胞系。用Montanide ISA 720中配制的单剂量ICC-1132获得的有希望的结果鼓励了该疟疾疫苗候选者的进一步临床开发。

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