Clinical Studies of Vaccines for Pandemic H1N1 Influenza

2009年4月，疾病控制和预防中心(CDC)报告了美国首两例人类感染新型甲型H1N1流感病毒的病例，在接下来的几周里，该病毒在世界各地传播，促使世界卫生组织(WHO)于2009年6月11日宣布全球流感大流行。新型甲型H1N1流感病毒的抗原性和基因特征表明，该病毒包含来自北美和欧亚猪流感病毒谱系的独特基因片段组合。从2009年大流行H1N1病毒感染的人类病例中分离出的病毒在抗原性上是同质的，在抗原性上与北美猪H1N1病毒相似，但与季节性人类甲型H1N1流感病毒不同。 根据抗原性和基因分析及流行病学资料，世界卫生组织选择A/California/7/2009(H1N1)病毒作为疫苗开发的参考病毒；大流行H1N1灭活疫苗和减毒活疫苗于2009年获得许可。我们启动了临床研究，以评估不同年龄段获得许可的灭活病毒和H1N1减毒活疫苗的免疫原性和传染性。对这些研究的数据的分析正在进行中。

In April 2009, the Centers for Disease Control and Prevention (CDC) reported the first two cases of human infection with a novel influenza A H1N1 virus in the United States and over the course of the next several weeks, the virus spread around the world prompting the World Health Organization (WHO) to declare a global influenza pandemic on June 11, 2009. Antigenic and genetic characterization of the novel influenza A H1N1 virus indicated that the virus contained a unique combination of gene segments from North American and Eurasian lineages of swine influenza viruses. The viruses isolated from human cases of the 2009 pandemic H1N1 virus infection were antigenically homogeneous and antigenically similar to North American swine H1N1 viruses, but distinct from seasonal human influenza A H1N1 viruses. Based on antigenic and genetic analysis and epidemiologic information, the WHO selected the A/California/7/2009 (H1N1) virus as the reference virus for vaccine development; inactivated and live attenuated vaccines for pandemic H1N1 were licensed in 2009. We initiated clinical studies to evaluate the immunogenicity and infectivity of the licensed inactivated virus and live attenuated H1N1 vaccines in different age groups. Analysis of the data from these studies is in progress.