Robbins J B, Schneerson R, Szu S C, Bryla D A, Lin F Y, Gotschlich E C
National Institute of Child Health and Human Development, NIH, Bethesda, MD 20892, USA.
Dev Biol Stand. 1998;95:161-7.
Standardization schemes devised by Control Agencies have followed clinical trials of experimental vaccines. The wealth of information about the pathogenesis of and immunity to bacteria, whose surface polysaccharides are protective antigens, now permits standardization to predict the efficacy of polysaccharide-based vaccines. There has been tacit acceptance of this notion with the licensure of groups Y and W135 meningococcal vaccines and of many of the pneumococcal types whose frequency in patients was too low for statistical significance to be assigned for their clinical efficacy. In fact, this was also the case for licensure of polio virus type 2 vaccine. We can reliably measure the level of anti-polysaccharide antibodies for meningococci, pneumococci, GBS and the Vi of S. typhi. Haemophilus type b conjugates have been reliably standardized by physico-chemical assays. New conjugates, therefore, may be licensed by data provided by standardization without awaiting the results of costly and time-consuming efficacy trials. Adoption of this scientifically-based approach to licensure will hasten the implementation of new and more effective vaccines.
控制机构制定的标准化方案是在实验性疫苗临床试验之后形成的。现在，关于表面多糖为保护性抗原的细菌的发病机制和免疫的大量信息，使得标准化能够预测基于多糖的疫苗的疗效。随着Y群和W135群脑膜炎球菌疫苗以及许多肺炎球菌类型疫苗的获批，这一概念已被默许接受，因为这些肺炎球菌类型在患者中的出现频率过低，以至于无法为其临床疗效赋予统计学意义。事实上，2型脊髓灰质炎病毒疫苗的获批也是如此。我们能够可靠地测量针对脑膜炎球菌、肺炎球菌、B族链球菌和伤寒沙门氏菌Vi抗原的抗多糖抗体水平。b型流感嗜血杆菌结合疫苗已通过物理化学分析进行了可靠的标准化。因此，新的结合疫苗可以根据标准化提供的数据获批，而无需等待耗时且成本高昂的疗效试验结果。采用这种基于科学的获批方法将加速新型更有效疫苗的推广应用。
