Bjune G, Closs O, Frøholm L O, Grønnesby J K, Høiby E A, Nøkleby H
National Institute of Public Health, Oslo.
NIPH Ann. 1991 Dec;14(2):81-91; discussion 91-3.
An outer membrane vesicle vaccine against acute, systemic disease caused by meningococci of serogroup B has been developed. The vaccine has been tested consecutively in phase I and phase II clinical trials including more than 5000 volunteers. These trials provided data on safety, immunogenicity and reactogenicity and possible effect on carriage of meningococci in the throat, and consequently formed the basis for two major protection trials; one in secondary school students and one among military recruits. The aims, design and major results of phase I and phase II studies are described as well as the design and organization of the protection trials.
一种针对由B群脑膜炎球菌引起的急性全身性疾病的外膜囊泡疫苗已研发成功。该疫苗已在包括5000多名志愿者的I期和II期临床试验中连续进行了测试。这些试验提供了关于安全性、免疫原性、反应原性以及对咽喉部脑膜炎球菌携带情况可能影响的数据，从而为两项主要的保护试验奠定了基础；一项在中学生中进行，另一项在新兵中进行。文中描述了I期和II期研究的目的、设计和主要结果，以及保护试验的设计和组织情况。
