安全性审查：两种针对B群脑膜炎奈瑟菌全身性疾病的外膜囊泡（OMV）疫苗。
Safety review: two outer membrane vesicle (OMV) vaccines against systemic Neisseria meningitidis serogroup B disease.
作者信息
Nøkleby H, Aavitsland P, O'Hallahan J, Feiring B, Tilman S, Oster P
机构信息
Norwegian Institute of Public Health (NIPH), P.O. Box 4404, Nydalen, N-0403 Oslo, Norway.
出版信息
Vaccine. 2007 Apr 20;25(16):3080-4. doi: 10.1016/j.vaccine.2007.01.022. Epub 2007 Jan 22.
MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac was developed for control of a B:15:P1.7,16 subtype epidemic in Norway and administered to 180,000 subjects in 28 clinical studies. MeNZB, a daughter vaccine of MenBvac, was developed for a clonal B:4:P1.7b,4 epidemic in New Zealand and administered to 1 million people <20 years. The vaccines were similar regarding reactogenicity profile. Serious adverse events (SAEs) in general and particularly neurologic SAEs were very rare. Despite frequently reported local reactions and fever in those under 5 years, these OMV-based vaccines containing 25 microg antigen can be considered safe for use in all age groups.
MenBvac是一种针对B群脑膜炎奈瑟菌全身性疾病的外膜囊泡疫苗。MenBvac是为控制挪威B:15:P1.7,16亚型疫情而研发的，并在28项临床研究中对18万名受试者进行了接种。MeNZB是MenBvac的衍生疫苗，是为控制新西兰B:4:P1.7b,4克隆株疫情而研发的，已对100万名20岁以下人群进行了接种。这两种疫苗在反应原性方面相似。一般严重不良事件（SAE），尤其是神经系统SAE非常罕见。尽管经常报告5岁以下儿童出现局部反应和发热，但这些含25微克抗原的基于外膜囊泡的疫苗可被认为对所有年龄组都是安全的。
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