Maheshwari S C, Sharma S B, Kumar A, Sokhey J
Central Research Institute, Kasauli (Himachal Pradesh), India.
J Commun Dis. 1998 Sep;30(3):139-46.
Eleven batches of Adsorbed Diphtheria-Tetanus (DT) vaccines and thirteen batches of Adsorbed Diphtheria-Pertussis-Tetanus (DTP) vaccines were tested for the potency of diphtheria and tetanus components by an Antibody Induction Method (AIM) developed in mice. The potency results obtained were found comparable and did not show any statistically significant difference with those obtained by WHO recommended lethal challenge tests for diphtheria in guinea pigs and for tetanus in mice. AIM in mice is more economical as both diphtheria and tetanus components of combined vaccine can be tested in the same experiment and the procedure also eliminates the use of guinea pigs required in the lethal challenge/conventional tests. The data obtained while testing tetanus component by the conventional antibody induction (IP) method in guinea pigs suggests that minimum requirements laid down in i.p. is too low which may be fixed as at least 3 out of 9 guinea pig sera and should contain > or = 4 units of tetanus antitoxin per ml.
采用在小鼠中开发的抗体诱导法（AIM），对11批吸附白喉-破伤风（DT）疫苗和13批吸附白喉-百日咳-破伤风（DTP）疫苗的白喉和破伤风成分效价进行了检测。所获得的效价结果具有可比性，与世界卫生组织推荐的豚鼠白喉致死性攻击试验和小鼠破伤风致死性攻击试验所获得的结果相比，未显示出任何统计学上的显著差异。小鼠中的AIM更经济，因为联合疫苗的白喉和破伤风成分都可以在同一实验中进行检测，而且该方法还避免了致死性攻击/传统试验中对豚鼠的使用。在豚鼠中通过传统抗体诱导（IP）法检测破伤风成分时获得的数据表明，腹腔注射规定的最低要求过低，可确定为9只豚鼠血清中至少3只血清，且每毫升应含有≥4单位破伤风抗毒素。
