Abstract：
The gram-negative bacterium Shigella is an enteric pathogen responsible for significant morbidity and mortality due primarily to severe diarrhea and dysentery, mainly among children younger than five years of age living in low- and middle-income countries (LMICs). Long considered a priority target for vaccine development, recent scientific advances have led to a number of promising Shigella vaccine candidates now entering advanced stages of clinical testing. Yet, there is no guarantee that even a highly efficacious Shigella vaccine will be recommended, prioritized, purchased, and widely adopted-especially if it requires additional doses in the immunization schedule and/or visits within the immunization program. This uncertainty is due to a variety of factors, including continuing declines in Shigella-specific and overall diarrheal disease mortality rates, the increasing complexity and cost of infant immunization programs in LMICs, and the recent availability of other high-priority vaccines. Since combining a Shigella vaccine with an existing infant vaccine would conceivably increase its attractiveness, there is a need to systematically consider the challenges determining the public health value, clinical development, manufacturing, licensure, policy recommendations, and financing for a Shigella-containing combination vaccine. The international non-governmental health organization PATH convened an independent panel of 34 subject matter experts across academic, industry, philanthropic, and global health sectors to discuss hypothetical combinations of a notional parenteral Shigella vaccine with three existing vaccines in order to begin exploring the challenges associated with their development. The resulting insights and recommendations from this meeting contribute to PATH\'s broader effort to evaluate the public health value of potential Shigella vaccines. They may also help guide future combination vaccine development efforts more broadly.
摘要：
革兰氏阴性细菌志贺氏菌是一种肠道病原体，主要由于严重的腹泻和痢疾而导致大量的发病率和死亡率。主要是生活在低收入和中等收入国家（LMICs）的5岁以下儿童。长期以来被认为是疫苗开发的优先目标，最近的科学进步导致许多有希望的志贺氏菌候选疫苗进入临床试验的高级阶段。然而，不能保证即使是高效的志贺氏菌疫苗也会被推荐，优先,购买,并被广泛采用-特别是如果它需要在免疫计划中增加剂量和/或在免疫计划中进行访问。这种不确定性是由多种因素造成的，包括志贺氏菌特异性和总体腹泻病死亡率的持续下降，LMIC婴儿免疫计划的复杂性和成本日益增加，以及最近其他高优先级疫苗的供应。由于将志贺氏菌疫苗与现有的婴儿疫苗结合使用会增加其吸引力，有必要系统地考虑确定公共卫生价值的挑战，临床发展，制造,执照,政策建议,和资助含有志贺氏菌的组合疫苗。国际非政府卫生组织PATH召集了一个由34名学术界主题专家组成的独立小组，工业,慈善,和全球卫生部门讨论假想的肠外志贺氏菌疫苗与三种现有疫苗的组合，以便开始探索与其开发相关的挑战。本次会议得出的见解和建议有助于PATH开展更广泛的工作，以评估潜在志贺氏菌疫苗的公共卫生价值。它们也可能有助于更广泛地指导未来的联合疫苗开发工作。
