Division of Bacteriology, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.
Toxins (Basel). 2019 Jul 17;11(7):417. doi: 10.3390/toxins11070417.
Whooping cough is caused by the bacterium . There are currently two types of vaccines that can prevent the disease; whole cell vaccines (WCV) and acellular vaccines (ACV). The main virulence factor produced by the organism is pertussis toxin (PTx). This toxin is responsible for many physiological effects on the host, but it is also immunogenic and in its detoxified form is the main component of all ACVs. In producing toxoid for vaccines, it is vital to achieve a balance between sufficiently detoxifying PTx to render it safe while maintaining enough molecular structure that it retains its protective immunogenicity. To ensure that the first part of this balancing act has been successfully achieved, assays are required to accurately measure residual PTx activity in ACV products accurately. Quality control assays are also required to ensure that the detoxification procedures are robust and stable. This manuscript reviews the methods that have been used to achieve this aim, or may have the potential to replace them, and highlights their continuing requirement as vaccines that induce a longer lasting immunity are developed to prevent the re-occurrence of outbreaks that have been observed recently.
百日咳是由细菌引起的。目前有两种疫苗可以预防这种疾病；全细胞疫苗（WCV）和无细胞疫苗（ACV）。该生物体产生的主要毒力因子是百日咳毒素（PTx）。这种毒素对宿主有许多生理影响，但它也是免疫原性的，其解毒形式是所有 ACV 的主要成分。在生产疫苗类毒素时，必须在使 PTx 充分解毒以使其安全的同时，保持足够的分子结构，以保持其保护性免疫原性，从而达到平衡。为了确保这一平衡行动的第一部分已经成功实现，需要进行测定来准确测量 ACV 产品中残留 PTx 活性的测定。还需要进行质量控制测定，以确保解毒程序稳定可靠。本文综述了已用于实现这一目标的方法，或可能具有替代它们的潜力，并强调了随着开发预防最近观察到的爆发的更持久免疫的疫苗，它们仍然需要作为不断发展的方法。
