Trial Watch
Trial Watch
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DOI：
10.1586/14760584.5.3.313
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发表时间：
2006-06
影响因子：
78.5
通讯作者：
中科院分区：
文献类型：
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作者：
上个月发表在《柳叶刀》杂志上的一项新研究显示，一种实验性的H5N1禽流感疫苗已被证明是安全的和免疫原性的。赛诺菲安万特生产的灭活疫苗用不同的配方进行了测试。科学家们发现，30毫克的两剂氢氧化铝佐剂效果最好。“我们测试的疫苗似乎是安全的，耐受性良好，我们确实看到了良好的免疫反应，”试验团队负责人梅勒妮·萨维尔说。它还符合欧洲对人类流感疫苗的监管要求。这项试验的另一个目的是减少疫苗剂量。目前人类流感疫苗的生产能力每年可生产3亿剂。提高这一能力是困难和昂贵的，因此配药策略对于满足需求是重要的。在早些时候的一项试验中，赛诺菲生产的另一种90毫克疫苗的两剂疫苗显示出令人满意的结果。剂量很重要，因为如果每剂疫苗需要更少的疫苗，更多的人可以受益。在这项试验中，低于30毫克的剂量显示了令人鼓舞的结果，尽管还需要进一步的研究。“我们很快就会进入第二阶段，”萨维尔补充道。其他制药公司也开始了临床试验。葛兰素史克正在研发两种抗H5N1病毒的疫苗，ChIron公司正在研发一种。如果H5N1禽流感病毒变异成一种高度传染性的毒株，可以在人类之间传播，那么它从亚洲传播到欧洲、中东和非洲的风险是一个突出的威胁。制药公司正在竞相开发H5N1疫苗，为可能出现的变异禽流感病毒大流行做准备。
An experimental H5N1 bird flu vaccine has been proved to be safe and immunogenic, as revealed by new research published in the journal the Lancet last month. The inactivated vaccine made by Sanofi Aventis was tested with various formulations. Scientists found a twodose regimen of 30 mg with aluminium hydroxide adjuvant produced the best outcome. ‘‘The vaccine that we tested appeared to be safe and well-tolerated and we did see a good immune response’’, said Melanie Saville, head of the trial team. It also met the European regulatory requirements for human influenza vaccine. Another aim of this trial was to reduce the vaccine dosage. The currnt production capacity for human influenza vaccines can make 300 million doses per year. Improving this capacity is difficult and expensive, hence dosing strategies are important to meet the demand. In an earlier trial, two doses of 90 mg of another vaccine produced by Sanofi showed a satisfactory result. The dosage is important as more people can benefit if less vaccine is needed per dose. In this trial, doses lower than 30 mg have revealed encouraging results, although further research is needed. ‘‘We will be moving into Phase II very shortly’’, added Saville. Other pharmaceutical companies have also started clinical trials. GlaxoSmithKline is working with two vaccines against the H5N1 virus and Chiron Corp with one. The risk of the H5N1 bird flu virus spreading from Asia to Europe, the Middle East and Africa presents a prominent threat if it mutates into a highly infectious strain that can be transmitted among humans. Drug companies are racing to develop a H5N1 vaccine to prepare for the possible pandemic of a mutated bird flu virus.