PATH, PO Box 900922, Seattle, WA 98109, USA.
PATH, PO Box 900922, Seattle, WA 98109, USA.
Vaccine. 2019 Aug 7;37(34):4800-4804. doi: 10.1016/j.vaccine.2019.02.060.
Development of an oral enteric vaccine for infants is important for Shigella and enterotoxigenic Escherichia coli (ETEC) vaccine development. At a recent workshop titled "Technical Product Attributes in Development of an Oral Enteric Vaccine for Infants," at the 2nd International Vaccines Against Shigella and ETEC Conference (VASE Conference), the preferred product attributes for development were discussed for these vaccines. The aims of this workshop were to identify gaps and gather opinions from key experts from preclinical, process development, manufacturing, regulatory, and clinical areas to fine-tune and refine key target product attributes for infant oral vaccine development. The workshop used some examples of marketed oral infant vaccines to discuss potential improvements that can be made, such as inclusion of preservatives, multidose vials, and antacid buffer presentation (liquid or lyophilized) in novel oral enteric vaccine development.
为婴儿开发口服肠道疫苗对于志贺氏菌和肠产毒性大肠杆菌（ETEC）疫苗的开发非常重要。在最近题为“开发婴儿口服肠道疫苗的技术产品属性”的专题研讨会上，在第二届国际志贺氏菌和 ETEC 疫苗会议（VASE 会议）上，讨论了这些疫苗的首选产品属性。该研讨会的目的是确定差距，并从临床前、工艺开发、制造、监管和临床领域的主要专家那里收集意见，以微调并完善婴儿口服疫苗开发的关键目标产品属性。该研讨会使用了一些市售的口服婴儿疫苗的例子来讨论可以进行的潜在改进，例如在新型口服肠道疫苗的开发中加入防腐剂、多剂量小瓶和抗酸缓冲液呈现（液体或冻干）。
