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以Seppic ISA 720配制的红细胞前期疟疾候选疫苗ICC-1132的安全性、免疫原性和有效性

Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720.

作者信息

Walther Michael, Dunachie Susanna, Keating Sheila, Vuola Jenni M, Berthoud Tamara, Schmidt Annette, Maier Carolin, Andrews Laura, Andersen Rikke F, Gilbert Sarah, Poulton Ian, Webster Daniel, Dubovsky Filip, Tierney Eveline, Sarpotdar Pramod, Correa Simon, Huntcooke Angela, Butcher Geoffrey, Williams Jack, Sinden Robert E, Thornton George B, Hill Adrian V S

机构信息

Nuffield Department of Clinical Medicine, Centre for Clinical Vaccinology and Tropical Medicine, Oxford University, Old Road, Headington, Oxford OX3 7LJ, UK.

出版信息

Vaccine. 2005 Jan 4;23(7):857-64. doi: 10.1016/j.vaccine.2004.08.020.

Abstract

ICC-1132, a recombinant virus-like particle comprising of a modified hepatitis B core protein with a B cell (NANP) and two T cell epitopes of Plasmodium falciparum circumsporozoite protein (CSP), was administered i.m. as a single 50 microg dose in Seppic ISA 720 to 11 volunteers. Local reactogenicity and systemic side effects were acceptable with the predominant finding being mild pain at the injection site. This regimen induced anti-NANP antibodies in 10/11 and modest T cell responses. There was no evidence of protection from experimental challenge with P. falciparum sporozoites. Other formulations and/or multi-dose regimens will be required to enhance the immunogenicity and efficacy of ICC-1132.

摘要

ICC - 1132是一种重组病毒样颗粒,由修饰的乙肝核心蛋白组成,带有一个B细胞(NANP)和恶性疟原虫环子孢子蛋白(CSP)的两个T细胞表位,以50微克单剂量肌肉注射于Seppic ISA 720中,给予11名志愿者。局部反应原性和全身副作用均可接受,主要发现是注射部位轻度疼痛。该方案在11名志愿者中的10名中诱导产生了抗NANP抗体,并产生了适度的T细胞反应。没有证据表明其对恶性疟原虫子孢子的实验性攻击具有保护作用。需要其他配方和/或多剂量方案来提高ICC - 1132的免疫原性和疗效。

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