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最近,美国Aviron公司就研制鼻内用流感疫苗,与美国国立变态反应与传染病研究所(NIAID)签订了一项合作研究与开发协议,并与密执安大学签订了许可证协议。该疫苗成份已在7000多人中进行过研究,证明是安全有效的。这是一种在较低温度(25℃左右)下培养数年的冷适应减毒活疫苗,在人体温度下无法复制。 该疫苗可鼻内接种,在粘膜中激发IgG抗体,它诱导的免疫保护作用比仅诱导血液IgG抗体的灭活疫苗更强、更持久。并且,鼻用疫苗是儿童每年接种的第一种实用方法。 该公司计划于1995年开始在儿童中进行Ⅰ/Ⅱ期研究,在1996~1997年及1997~1998年冬季流感流行季节进行Ⅲ期研究。用大颗粒气溶胶喷雾器进行接种。这些试验将根据现行三价流感疫苗的标准进行。由于流感病毒株每年不同,美国食品和药物管理局坚持,每年的流感疫苗应重新配方以抵抗三种最常见的流行株。Aviron公司称,很容易改变
More recently, Aviron, a U.S. company, has developed a collaborative research and development agreement with the National Institute of Allergy and Infectious Diseases (NIAID) for the development of an intranasal influenza vaccine and has entered into a licensing agreement with the University of Michigan. The vaccine ingredients have been studied in more than 7000 people, proved to be safe and effective. This is a cold-adapted attenuated live vaccine that is cultivated at lower temperatures (around 25 ° C) for several years and can not be replicated at body temperature. The vaccine, which can be administered intranasally, excites IgG antibodies in the mucosa, induces a stronger and more prolonged immune protection than an inactivated vaccine that induces only blood IgG antibodies. And nasal vaccines are the first practical method of vaccinating children each year. The company plans to start Phase I / II studies in children starting in 1995 and Stage III studies in the winter flu season from 1996 to 1997 and from 1997 to 1998. Inoculate with large particle aerosol spray. These trials will be based on the current trivalent flu vaccine standards. As influenza strains vary from year to year, the FDA insists that annual flu vaccines should be reprocessed against the three most common pandemic strains. Aviron says it’s easy to change