Safety and immunogenicity of a three-component blood-stage malaria vaccine (MSP1, MSP2, RESA) against Plasmodium falciparum in Papua New Guinean children
Safety and immunogenicity of a three-component blood-stage malaria vaccine (MSP1, MSP2, RESA) against Plasmodium falciparum in Papua New Guinean children
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DOI：
10.1016/s0264-410x(03)00536-x
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发表时间：
2003-12-08
期刊：
影响因子：
5.5
通讯作者：
Alpers, MP
中科院分区：
文献类型：
--
作者：
Genton, B;Al-Yaman, F;Alpers, MP
组合B是一种疟疾疫苗，其包含重组恶性疟原虫（P falciparum）血液阶段蛋白MSP 1、MSP 2和RESA，与佐剂Montanide伊萨720一起配制。在120名5-9岁儿童中进行了I-IIb期双盲随机安慰剂对照试验。受试者随机分为四组：（i）无磺胺嘧啶-乙胺嘧啶（SP）+疫苗，（ii）无SP +安慰剂，（iii）SP +疫苗，（iv）SP +安慰剂。在第一次和第二次注射（间隔4周）时，在大腿中给予15 μ g每种蛋白质。安慰剂为生理盐水乳化佐剂，未发生严重或重度AE。第一次注射后，3%的疫苗接种者和3%的安慰剂接种者发生中度AE，第二次注射后分别为12%和10%。疫苗诱导了对所有三种抗原的显著抗体应答，但仅触发了对MSPI的IFN-γ应答。在第12周，在未给予SP的疫苗组中，IFN-γ对MSP 1的应答显著更高。证明组合B在5-9岁儿童中是安全的和免疫原性的。疫苗免疫原性既不受循环寄生虫的损害，也不增加后，预处理与SP和预处理是不可取的，在未来的试验疟疾疫苗，至少是那些包括血液阶段抗原。(C)2003 Elsevier Ltd.保留所有权利。
Combination B is a malaria vaccine that comprises recombinant Plasmodium falciparum (P falciparum) blood-stage proteins MSP1, MSP2 and RESA, formulated with the adjuvant Montanide ISA 720. A phase I-IIb double-blind randomised placebo-controlled trial was undertaken in 120 children aged 5-9 years. Subjects were randomised in four groups: (i) No sulphadoxine-pyrimethamine (SP) + vaccine, (ii) No SP + placebo, (iii) SP + vaccine, (iv) SP + placebo. 15 mug of each protein were given in the thigh, at both first and second injection (4 weeks apart). The placebo was adjuvant emulsified with saline.No serious or severe AEs occurred. Moderate AEs were seen in 3% of the vaccine and 3% of the placebo recipients after first injection and in 12 and 10% after second injection. The vaccine induced significant antibody responses to all three antigens but triggered an IFN-gamma response to MSPI only. At Week 12, the IFN-gamma response to MSP1 was substantially higher in the vaccine group where No SP had been given.Combination B proved to be safe and immunogenic in children aged 5-9 years. Vaccine immunogenicity was neither impaired by circulating parasites nor increased after pre-treatment with SP and pre-treatment is not advisable in future trials of malaria vaccines, at least for those including blood-stage antigens. (C) 2003 Elsevier Ltd. All rights reserved.