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Preclinical evaluation of the synthetic adjuvant SQS-21 and its constituent isomeric saponins.

机译：合成佐剂SQS-21及其组成异构体皂苷的临床前评价。

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The saponin fraction QS-21 from Quillaja saponaria has been demonstrated to be a potent immunological adjuvant when mixed with keyhole limpet hemocyanin conjugate vaccines, as well as with other classes of subunit antigen vaccines. QS-21 adjuvant is composed of two isomers that include the apiose and xylose forms in a ratio of 65:35, respectively. The chemical syntheses of these two isomers in pure form have recently been disclosed. Herein we describe detailed in vivo immunological evaluations of these synthetic QS-21 isomeric constituents, employing the GD3-KLH melanoma antigen. With this vaccine construct, high antibody titers against GD3 ganglioside and KLH were elicited when GD3-KLH was co-administered with adjuvant, either as the individual separate synthetic QS-21 isomers (SQS-21-Api or SQS-21-Xyl), or as its reconstituted 65:35 isomeric mixture (SQS-21). These antibody titer levels were comparable to that elicited by vaccinations employing naturally derived QS-21 (PQS-21). Moreover, toxicities of the synthetic saponin adjuvants were also found to be comparable to that of naturally derived PQS-21. These findings demonstrate unequivocally that the adjuvant activity of QS-21 resides in these two principal isomeric forms, and not in trace contaminants within the natural extracts. This lays the foundation for future exploration of structure-function correlations to enable the discovery of novel saponins with increased potency, enhanced stability, and attenuated toxicity.
机译：已证明，来自 Quillaja saponaria 的皂苷组分QS-21与匙孔hole血蓝蛋白结合疫苗以及其他类型的亚单位抗原疫苗混合后，是一种有效的免疫佐剂。 QS-21佐剂由两种异构体组成，分别包括比例为65:35的apiose和木糖形式。最近公开了纯形式的这两种异构体的化学合成。本文中，我们利用GD3-KLH黑色素瘤抗原，详细描述了这些合成QS-21异构体的体内免疫学评估。使用此疫苗构建体，当将GD3-KLH与佐剂（单独的单独合成QS-21异构体（SQS-21-Api或SQS-21-Xyl）作为佐剂共同给药时，会引起针对GD3神经节苷脂和KLH的高抗体滴度，或其重构的65:35异构体混合物（SQS-21）。这些抗体效价水平与使用天然来源的QS-21（PQS-21）接种疫苗所诱导的抗体效价水平相当。此外，还发现合成皂苷佐剂的毒性可与天然来源的PQS-21媲美。这些发现明确表明，QS-21的佐剂活性以这两种主要的异构形式存在，而不是天然提取物中的痕量污染物。这为将来探索结构-功能相关性奠定了基础，从而使人们能够发现具有增强功效，增强稳定性和减弱毒性的新型皂苷。

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