小孩对于新的H1N1疫苗反应与对季节性流感疫苗一样


  September 21, 2009 — 根据国家健康研究中心所属之国家过敏与感染症研究中心(NIAID)赞助的一篇试验结果,单一剂量、15-μg的无佐剂2009 H1N1流感疫苗,在一些10至17岁孩童接种后8到10天产生对抗病毒的免疫反应。
  
  NIAID表示,这些初步结果看起来有希望。
  
  NIAID主任Anthony S. Fauci医师在声明中表示,这是很令人鼓舞的新闻。如同我们希望的,对于2009 H1N1流感疫苗的反应,相似于以同样方法生产、常规使用之季节性流感疫苗的结果。对于10至17岁的小孩,H1N1流感疫苗只需要一剂15-μg的剂量。2009 H1N1流感病毒正引起全球孩童的传染,因此我们乐见此一疫苗的研究结果。
  
  这项进行中的试验,检视一剂和两剂15或30 μg疫苗的免疫反应,研究对象依年龄分为三组:6到35个月、3到9岁、10到17岁的孩童。
  
  今天发表的初步结果,是根据初次接种后8到10天的血液样本。结果显示,10至17岁组的免疫反应最强,在该组的25个孩童中,接受15-μg单一剂量的小孩有19个(76%)有强烈免疫反应。3到9岁组的25个小孩中,9个小孩(36%)有强烈免疫反应,6到35个月的20个小孩中,15-μg 单一剂量疫苗让5个(25%)小孩产生强烈免疫反应。
  
  Fauci医师表示,这些结果并不意外,和季节性流感疫苗所见一致,且与我们以及食品药物管理局同僚的预测一致。
  
  该研究正继续评估第一次和第二次接种疫苗之后三周的免疫反应。NIAID预期孩童对于2009 H1N1流感疫苗的免疫反应类似于对季节性流感疫苗,且将在接种后数周继续增加。
  
  检测使用的疫苗是由Sanofi Pasteur所生产。
  

New H1N1 Vaccine Works Like Seasonal Flu Vaccine in Children

By Fran Lowry
Medscape Medical News

September 21, 2009 — A single, 15-μg dose of a nonadjuvanted 2009 H1N1 influenza vaccine generated an immune response against the virus in a small group of children aged 10 to 17 years at 8 to 10 days after vaccination, according to early results from a trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

These early results look promising, the NIAID said.

"This is very encouraging news. As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way," Anthony S. Fauci, MD, director of NIAID, said in a statement. "It seems likely that the H1N1 flu vaccine will require just one 15-μg dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results."

The trial, which is ongoing, is testing the safety and immune responses to 1 and 2 doses of either 15 or 30 μg of vaccine in 3 age groups: children aged 6 to 35 months, 3 to 9 years, and 10 to 17 years.

The early results announced today were based on blood samples taken 8 to 10 days after the first vaccination. The strongest immune response was seen in the 10- to 17-year-old age group. Among the 25 children in this group, a strong immune response was seen in 19 children (76%) who received a single 15-μg dose. Among the 25 children in the 3- to 9-year-old age group, 9 children (36%) demonstrated a strong immune response, and in the 20 children aged 6 to 35 months, a single 15-μg dose of vaccine produced a strong immune response in 5 children (25%).

"These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated," Dr. Fauci said.

The study is continuing to assess immune response to the vaccine 3 weeks after both the first and second vaccinations. The NIAID anticipates that the immune response in children to the 2009 H1N1 flu vaccine will be similar to that of seasonal influenza vaccination and will continue to increase for several weeks after vaccination.

The vaccine being tested is manufactured by Sanofi Pasteur.

    
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