Paoletti L C
Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
Vaccine. 2001 Feb 28;19(15-16):2118-26. doi: 10.1016/s0264-410x(00)00437-0.
The potency of clinical group B streptococcal (GBS) capsular polysaccharide-protein conjugate vaccines has been assessed with use of a mouse maternal vaccination-neonatal pup challenge model of GBS disease. Two of the three conjugated GBS vaccines bottled as liquid preparations showed a potency reduction from 100% to < or = 50% in 3 years; whereas all six vaccines bottled as lyophilized preparations with sucrose excipient exhibited no loss of potency during the same span of time. A reconstituted GBS conjugate vaccine remained potent and antigenically intact after 31 days' storage at 2-8 degrees C. These data suggest that lyophilization in the presence of sucrose extends the potency of GBS conjugate vaccines.
已通过使用B族链球菌(GBS)疾病的小鼠母体疫苗接种-新生幼崽攻毒模型,对临床用B族链球菌荚膜多糖-蛋白结合疫苗的效力进行了评估。三种瓶装为液体制剂的结合GBS疫苗中有两种在3年内效力从100%降至≤50%;而所有六种瓶装为含蔗糖赋形剂的冻干制剂的疫苗在同一时间段内未出现效力损失。一种重组GBS结合疫苗在2-8℃储存31天后仍保持效力且抗原完整。这些数据表明,在蔗糖存在下进行冻干可延长GBS结合疫苗的效力。