Safety, tolerability and humoral immune responses after intramuscular administration of a malaria DNA vaccine to healthy adult volunteers
Safety, tolerability and humoral immune responses after intramuscular administration of a malaria DNA vaccine to healthy adult volunteers
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DOI：
10.1016/s0264-410x(99)00407-7
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发表时间：
2000-03-17
期刊：
影响因子：
5.5
通讯作者：
Hoffman, SL
中科院分区：
文献类型：
--
作者：
Le, TP;Coonan, KM;Hoffman, SL
基于DNA的疫苗被认为是潜在的革命性的，因为它们易于生产，成本低，保质期长，不需要冷链和诱导良好的T细胞应答的能力。20名健康成年志愿者参加了编码疟疾抗原的DNA疫苗的I期安全性和耐受性临床研究。志愿者每月接受3次肌内注射四种不同剂量（20、100、500和2500 μ g）的恶性疟原虫环子孢子蛋白（PfCSP）质粒DNA中的一种，并随访长达12个月。局部反应原性和全身症状少而轻。没有严重或严重的不良事件，临床显著的生化或血液学变化，或可检测到的抗dsDNA抗体。尽管诱导了极好的CTL应答，但通过针注射的肌内DNA疫苗接种未能在任何志愿者中诱导可检测的抗原特异性抗体。出版社：Elsevier Science Ltd
DNA-based vaccines are considered to be potentially revolutionary due to their ease of production, low cost, long shelf life, lack of requirement for a cold chain and ability to induce good T-cell responses. Twenty healthy adult volunteers were enrolled in a Phase I safety and tolerability clinical study of a DNA vaccine encoding a malaria antigen. Volunteers received 3 intramuscular injections of one of four different dosages (20, 100, 500 and 2500 mu g) of the Plasmoditum falciparum circumsporozoite protein (PfCSP) plasmid DNA at monthly intervals and were followed for up to twelve months. Local reactogenicity and systemic symptoms were few and mild. There were no severe or serious adverse events, clinically significant biochemical or hematologic changes, or detectable anti-dsDNA antibodies. Despite induction of excellent CTL responses, intramuscular DNA vaccination via needle injection failed to induce detectable antigen-specific antibodies in any of the volunteers. Published by Elsevier Science Ltd.