Xing D K, Gaines Das R, Newland P, Corbel M
Division of Bacteriology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.
Biologicals. 2001 Jun;29(2):133-6. doi: 10.1006/biol.2001.0287.
The first British Standard (BS) (Code 66/303) for pertussis whole cell vaccine was prepared from the same suspension of Bordetella pertussis as the now exhausted Second International Standard for Pertussis Vaccine (2ndIS). The BS and the 2ndIS were compared and calibrated in a previous international study. This report describes a small international study, which included the BS, the 1stIS and the 2ndIS so that the present relationship of these preparations to one another could be assessed. The results of this study show that the relationship of the BS to the 1stIS is consistent with its established unitage of 46 IU per ampoule. The results further show that the potency of the BS is broadly consistent with that of the 2ndIS and that the BS has not lost activity relative to the 2ndIS (from which it was previously found to be indistinguishable). Based on its original calibration and supported by the results of this present study, the BS has been established as the Third International Standard for Pertussis Vaccine, with an assigned unitage of 46 IU per ampoule.
首个用于百日咳全细胞疫苗的英国标准（BS）（编号66/303），是由与现已耗尽的第二版百日咳疫苗国际标准品（2ndIS）相同的百日咳博德特氏菌悬液制备而成。在之前的一项国际研究中，对BS和2ndIS进行了比较和校准。本报告描述了一项小型国际研究，该研究纳入了BS、第一版国际标准品（1stIS）和2ndIS，以便评估这些制剂相互之间目前的关系。这项研究的结果表明，BS与1stIS的关系与其每安瓿46国际单位的既定效价一致。结果还进一步表明，BS的效力与2ndIS的效力大致一致，且BS相对于2ndIS（先前发现二者难以区分）并未丧失活性。基于其最初的校准并得到本研究结果的支持，BS已被确立为第三版百日咳疫苗国际标准品，其指定效价为每安瓿46国际单位。
