Deng James Z, Kuster Nathan, Drumheller Ashley, Lin Mingxiang, Ansbro Frances, Grozdanovic Milica, Samuel Rachelle, Zhuang Ping
Vaccine Analytical Research & Development, Analytical Research & Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
Analytical External Capabilities, Analytical Research & Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
NPJ Vaccines. 2023 Jan 23;8(1):2. doi: 10.1038/s41541-022-00584-9.
Bacterial infection remains as one of the major healthcare issues, despite significant scientific and medical progress in this field. Infection by Streptococcus Pneumoniae (S. Pneumoniae) can cause pneumonia and other serious infectious diseases, such as bacteremia, sinusitis and meningitis. The pneumococcal capsular polysaccharides (CPS) that constitute the outermost layer of the bacterial cell are the main immunogens and protect the pathogen from host defense mechanisms. Over 90 pneumococcal CPS serotypes have been identified, among which more than 30 can cause invasive pneumococcal diseases that could lead to morbidity and mortality. Multivalent pneumococcal vaccines have been developed to prevent diseases caused by S. Pneumoniae. These vaccines employ either purified pneumococcal CPSs or protein conjugates of these CPSs to generate antigen-specific immune responses for patient protection. Serotype-specific quantitation of these polysaccharides (Ps) antigen species are required for vaccine clinical dosage, product release and quality control. Herein, we have developed an antibody-enhanced high-performance liquid chromatography (HPLC) assay for serotype-specific quantitation of the polysaccharide contents in multivalent pneumococcal conjugate vaccines (PCVs). A fluorescence-labeled multiplex assay format has also been developed. This work laid the foundation for a serotype-specific antigen assay format that could play an important role for future vaccine research and development.
尽管在该领域取得了重大的科学和医学进展，但细菌感染仍然是主要的医疗保健问题之一。肺炎链球菌感染可导致肺炎和其他严重传染病，如菌血症、鼻窦炎和脑膜炎。构成细菌细胞最外层的肺炎球菌荚膜多糖（CPS）是主要的免疫原，可保护病原体免受宿主防御机制的影响。已鉴定出90多种肺炎球菌CPS血清型，其中30多种可导致侵袭性肺炎球菌疾病，进而可能导致发病和死亡。已开发出多价肺炎球菌疫苗来预防肺炎链球菌引起的疾病。这些疫苗采用纯化的肺炎球菌CPS或这些CPS的蛋白质偶联物来产生抗原特异性免疫反应以保护患者。疫苗临床剂量、产品放行和质量控制需要对这些多糖（Ps）抗原种类进行血清型特异性定量。在此，我们开发了一种抗体增强高效液相色谱（HPLC）法，用于多价肺炎球菌结合疫苗（PCV）中多糖含量的血清型特异性定量。还开发了一种荧光标记多重检测形式。这项工作为血清型特异性抗原检测形式奠定了基础，该检测形式可能对未来疫苗研发发挥重要作用。
