Kurzątkowski Wiesław, Kartoğlu Ümit, Staniszewska Monika, Górska Paulina, Krause Aleksandra, Wysocki Mirosław Jan
National Institute of Public Health-National Institute of Hygiene, Division of Epidemiology and Microbiology, Warsaw, Poland.
Biologicals. 2013 Mar;41(2):71-6. doi: 10.1016/j.biologicals.2011.10.011. Epub 2011 Nov 21.
This study was planned to evaluate structural damages in adsorbed vaccines affected by freezing using scanning electron microscopy and X-ray analysis of the elements. Randomly selected 42 vials of eight different types of WHO pre-qualified adsorbed freeze-sensitive vaccines from 10 manufacturers were included in the study. Vaccines were kept at 5 °C. Selected numbers of vials from each type were then exposed to -25 °C for 24 h periods. All samples were evaluated for their structure using scanning electron microscopy, X-ray analysis of the elements and precipitation time. Scanning electron microscopy of vaccines affected by freezing showed either smooth or rough surfaced conglomerates associated with phosphate content of the precipitate. These vaccines precipitated 2-15 times faster compared to non-frozen samples. Non-frozen samples showed uniform flocculent structure either dense or dispersed. X-ray analysis of precipitates in frozen samples confirmed that the precipitate is mainly aluminium clutters. Scanning electron microscopy confirmed that the lattice structure of bonds between adsorbent and the antigen is broken and aluminium forms conglomerates that grow in size and weight. The precipitation time of vaccines affected by freezing is 4.5 times faster on average compared to non-frozen samples. These facts form the basis of the "shake test".
本研究旨在通过扫描电子显微镜和元素X射线分析来评估受冷冻影响的吸附疫苗的结构损伤。该研究纳入了从10家制造商随机选取的42瓶8种不同类型的世卫组织预认证吸附型冻敏疫苗。疫苗保存在5°C。然后从每种类型中选取一定数量的小瓶，在-25°C下暴露24小时。所有样品均通过扫描电子显微镜、元素X射线分析和沉淀时间来评估其结构。对受冷冻影响的疫苗进行扫描电子显微镜检查发现，与沉淀物中的磷酸盐含量相关的聚集体表面要么光滑要么粗糙。与未冷冻的样品相比，这些疫苗的沉淀速度快2至15倍。未冷冻的样品呈现出致密或分散的均匀絮状结构。对冷冻样品中的沉淀物进行X射线分析证实，沉淀物主要是铝凝块。扫描电子显微镜证实，吸附剂与抗原之间键的晶格结构被破坏，铝形成了尺寸和重量不断增加的聚集体。与未冷冻的样品相比，受冷冻影响的疫苗的沉淀时间平均快4.5倍。这些事实构成了“摇瓶试验”的基础。
