Frasch C E, Mocca L F, Karpas A B
Office of Biologics, Food and Drug Administration, Bethesda, MD 20892.
Antonie Van Leeuwenhoek. 1987;53(6):395-402. doi: 10.1007/BF00415493.
There has been a decrease in the prevalence of disease in the United States due to meningococcal serotypes 2a and 2b containing class 2 proteins with a concomitant increase in nonserotypable strains containing class 3 major outer membrane proteins. A new disease associated strain was identified using monoclonal antibodies as B:4:P1.15. Serotype 4 strains have been heretofore isolated almost only from carriers. This B:4:P1.15 strain predominated among group B disease isolates in Cuba from the late 1970s to the present and among Miami, Florida isolates recovered in 1981 and 1982. To determine whether protein vaccines for new strains or serotypes could be prepared using our present methods, a combined vaccine was prepared from a group B strain (B:8:P1.15) recovered during a recent outbreak in Virginia, and a serotype 2b strain, plus group C polysaccharide. The vaccine was prepared with aluminum hydroxide, or with trehalose dimycolate plus monophosphoryl lipid A, or without adjuvant. Four weeks after immunization antibody levels were much higher in mice that received vaccine containing adjuvant.
由于含有2类蛋白的2a和2b型脑膜炎球菌血清型在美国的疾病流行率有所下降,与此同时,含有3类主要外膜蛋白的不可分型菌株有所增加。使用单克隆抗体鉴定出一种新的疾病相关菌株为B:4:P1.15。此前,4型血清型菌株几乎仅从携带者中分离得到。从20世纪70年代末至今,这种B:4:P1.15菌株在古巴B群疾病分离株中占主导地位,在1981年和1982年从佛罗里达州迈阿密分离得到的菌株中也占主导地位。为了确定能否用我们目前的方法制备针对新菌株或血清型的蛋白疫苗,我们从弗吉尼亚州最近一次疫情中分离出的一株B群菌株(B:8:P1.15)、一株2b型血清型菌株以及C群多糖制备了一种联合疫苗。该疫苗用氢氧化铝制备,或用海藻糖二霉菌酸酯加单磷酰脂质A制备,或不添加佐剂。免疫四周后,接种含佐剂疫苗的小鼠体内抗体水平要高得多。