今天上网，看到权威医学杂志新英格兰发表了关于甲流疫苗初期临床数据的两篇文章，贴出来大家看看，希望感兴趣的朋友结合我国甲流的临床试验发表下意见
第一篇和我国的临床实验设计方案大致相同，参考季节性流感疫苗免疫剂量与策略，文章对一针后的免疫效果及安全性数据进行评估，得出的结论也是15ug即可在成人中诱导良好免疫应答，与季节性流感疫苗相同，与我国各大厂商临床试验得出的数据相同，说明我国疫苗研发水平已经达到发达国家的水平，相关部门领导又可以在自慰中集体达到高潮(盛世和谐~~~)，祝贺下！
看了下关于副反应的一些数据，国外的不良反应要高于科兴公布的数据，这个是否具有显著差异，还是因为国人的一些特殊状况造成的这种结果？
附上摘要
Response after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine — Preliminary Report
Background A novel influenza A (H1N1) 2009 virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is urgently needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia.
Methods This preliminary report evaluates the immunogenicity and safety of the vaccine 21 days after the first of two scheduled doses. A total of 240 subjects, equally divided into two age groups (<50 years and 50 years), were enrolled and underwent randomization to receive either 15 μg or 30 μg of hemagglutinin antigen by intramuscular injection. We measured antibody titers using hemagglutination-inhibition and microneutralization assays at baseline and 21 days after vaccination. The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer.
Results By day 21 after vaccination, antibody titers of 1:40 or more were observed in 116 of 120 subjects (96.7%) who received the 15-μg dose and in 112 of 120 subjects (93.3%) who received the 30-μg dose. No deaths, serious adverse events, or adverse events of special interest were reported. Local discomfort (e.g., injection-site tenderness or pain) was reported by 46.3% of subjects, and systemic symptoms (e.g., headache) by 45.0% of subjects. Nearly all events were mild to moderate in intensity.
Conclusions A single 15-μg dose of 2009 H1N1 vaccine was immunogenic in adults, with mild-to-moderate vaccine-associated reactions. (ClinicalTrials.gov number, NCT00938639 [ClinicalTrials.gov] .)
cuturl('http://content.nejm.org/cgi/content/full/NEJMoa0907413?query=TOC')作者: #问号# 时间: 2014-8-9 16:35
第二篇是应用了MF59佐剂，临床试验结果也非常不错，有兴趣的朋友可以看看
Background The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.
Methods We conducted a single-center study, involving 175 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 μg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-μg doses of MF59-adjuvanted vaccine, or 7.5 or 15 μg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.
Results Results of an interim analysis of the responses to the 7.5-μg dose of MF59-adjuvanted vaccine by days 14 and 21 are presented (data from four of the seven groups studied, for a total of 100 subjects). The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively. Two subjects reported fever, with a temperature of 38°C or higher, after the first dosing. Antibody titers, expressed as geometric means, were generally higher at day 14 among subjects who had received two 7.5-μg doses of the MF59-adjuvanted vaccine than among those who had received only one by this time point (P=0.04 by the hemagglutination-inhibition assay and P<0.001 by the microneutralization assay). By 21 days after vaccination with the first dose of 7.5 μg of MF59-adjuvanted vaccine, the rates of seroconversion, as measured with the use of a hemagglutination-inhibition assay and a microneutralization assay, were 76% and 92% of subjects, respectively, who had received only one dose to date (with the second dose scheduled for day 21) and 88 to 92% and 92 to 96% of subjects, respectively, who had already received both doses (P=0.11 and P=0.64, respectively).
Conclusions In preliminary analyses, the monovalent influenza A (H1N1) 2009 MF59-adjuvanted vaccine generates antibody responses likely to be associated with protection within 14 days after a single dose is administered. (ClinicalTrials.gov number, NCT00943358 [ClinicalTrials.gov] .)
cuturl('http://content.nejm.org/cgi/content/full/NEJMoa0907650?query=TOC')作者: #问号# 时间: 2014-8-9 16:36
FDA是批准了四家疫苗厂商(鼎鼎有名),我看了详细报道，我的结论是FDA和SFDA一样果断
您从哪里看出FDA仅仅采纳了一剂免后10天的数据？从Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine？ 人家只是说明其诱导的免疫应答与季节性流感疫苗相似，而不是之前很多人推测由于人群处于免疫空白状态，其需要两针才会诱导有效免疫应答，人家的临床试验数据这么清晰明了，为什么不好好看看？关于中国临床数据，你自己算算时间，SFDA根据两剂免后21天，可能么？第二针的结果未出科兴都通过审批了，还两剂免后21天，这是个笑话！
现在的流感疫苗大多都汗防腐剂，怎么了？影响其使用了？再说，人家FDA批准的也有不含防腐剂的，您视而不见？As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
什么叫批准后四周批签发？您从哪里看出FDA的四周内可以批签发？是不是这句话？The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.人家的意思FDA已经审批通过(The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus)，四周内可获得首批大量疫苗吧
天，我以为我们看的不是同一篇文章，my god作者: idea2011 时间: 2014-8-9 16:39
相关疾病：
流行性感冒禽流感
中国成为世界首个可应用H1N1流感疫苗的国家，这一举措受到多国媒体的关注，最新一期的《科学》杂志也发表了一篇专题文章China First to Vaccinate Against Novel H1N1 Virus。
几个月前，中国启用极其严格的关口监测体系严防新流感H1N1病毒的入侵，当输入性病例已经变得无从防范时，中国政府也已经想好对策，尽早开发新流感疫苗，确保13亿人口的安全。华盛顿大学生物统计学家Ira Longini称赞道：中国的成绩是令人印象深刻的。
到9月14日止，中国当局估计将有650,000剂疫苗储备量，到9月底，储备量将达到7百万。
中国卫生部部长陈竺在接受《科学》专访时表示，中国政府大力发展流感疫苗的目的保护中国脆弱的卫生系统。希望在今年秋冬季能推迟流感疫情高峰期的到来，更主要的是希望能减少严重病例，降低死亡率。
卫生部另一名官员梁万年对Science对记者表示，中国这次快速的流感疫苗反应行动是出于国情的考虑，中国人口密度高，农村地区医疗系统不完善，缺乏足够的抗病毒储备等等问题使得我们必须尽快开发疫苗以保证打赢这场抗流感战役。
此外，梁万年还有另一重的担忧，中国秋冬季节有散发的禽流感疫情，以往的经验看，禽流感的死亡率高达50%，因此，我们希望新流感H1N1的疫苗能降低禽流感H5N1与新流感H1N1相遇杂交的机会。
梁万年还对《科学》记者谈了中国前期抵抗流感的策略问题。
对于新流感疫苗究竟接种几针的问题，中国的科学家还在持续的争论中，不久前《新英格兰医学杂志》发表了澳大利亚科学家确定一针有效的科研成果，但是，他们的研究是建立在成人疫苗接种的研究上的，对于儿童不一定适用，因此，有待进一步的探讨研究。
面对，未来的形势，陈竺有信心地表示：we can keep the situation under control。作者: #问号# 时间: 2014-8-9 16:40
终于看到NEJM上刊发了中国甲流疫苗临床试验结果的文章，本来感觉科兴应该更快些的，可这篇文章是华兰生物和江苏省CDC合作在泰州进行临床试验的结果，主要提到了疫苗在不同年龄组的免疫效果，与之前Greenberg et al等所发比较，多了儿童组和老年组，效果不用说了，前段时间官方一直大力宣扬，文章偷懒了，没有做微量中和试验，不过能发到新英格兰，可喜可贺！
