Enterotoxigenic Escherichia coli (ETEC) vaccines: Priority activities to enable product development, licensure, and global access.
Enterotoxigenic Escherichia coli (ETEC) vaccines: Priority activities to enable product development, licensure, and global access.
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DOI：
10.1016/j.vaccine.2021.04.018
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发表时间：
2021-07-13
期刊：
影响因子：
5.5
通讯作者：
Louis Bourgeois A
中科院分区：
文献类型：
--
作者：
Khalil I;Walker R;Porter CK;Muhib F;Chilengi R;Cravioto A;Guerrant R;Svennerholm AM;Qadri F;Baqar S;Kosek M;Kang G;Lanata C;Armah G;Wierzba T;Hasso-Agopsowicz M;Giersing B;Louis Bourgeois A
产肠毒素大肠杆菌（ETEC）引起的腹泻病造成大量发病率和死亡率，主要发生在低收入和中等收入国家的儿科人群中。除了急性疾病外，人们还日益认识到肠道感染，包括肠外热带病，对儿童生长发育的长期影响。提供饮用水和卫生设施以及为急性病提供适当的临床护理对于减轻ETEC负担至关重要。然而，这些干预措施并不总是实际可行的，可能无法实现公平和可持续的覆盖。疫苗接种可能是最具成本效益和最公平的初级预防手段；然而，需要更多的数据来加速ETEC疫苗的投资和指导决策过程。首先，为了了解和量化ETEC疾病负担，需要更多关于ETEC感染与身体和认知发育迟缓以及受教育程度延迟之间关系的数据。此外，不适当或不充分的抗生素治疗可能会导致腹泻的抗菌药物耐药性（AMR），这需要进一步阐明。一种能减轻急性腹泻病和尽量减少长期疾病表现的ETEC疫苗可产生重大的公共卫生影响，是一种具有成本效益的对策。在此，我们回顾了ETEC疫苗管道，以符合世界卫生组织最近制定的首选产品特性（PPC）一般参数的候选疫苗为主导。此外，我们还制定了ETEC疫苗开发战略，为研究人员、资助者和疫苗制造商的优先活动提供一个框架，其目标是解决研究、产品开发和政策以及商业化和交付领域全球未满足的数据需求。该战略还旨在指导确定优先次序和协调所需的优先活动，以尽量缩短ETEC疫苗的许可和使用时间，特别是在最迫切需要疫苗的低收入和中等收入国家。
Diarrhoeal disease attributable to enterotoxigenic Escherichia coli (ETEC) causes substantial morbidity and mortality predominantly in paediatric populations in low- and middle-income countries. In addition to acute illness, there is an increasing appreciation of the long-term consequences of enteric infections, including ETEC, on childhood growth and development. Provision of potable water and sanitation and appropriate clinical care for acute illness are critical to reduce the ETEC burden. However, these interventions are not always practical and may not achieve equitable and sustainable coverage. Vaccination may be the most cost-effective and equitable means of primary prevention; however, additional data are needed to accelerate the investment and guide the decision-making process for ETEC vaccines. First, to understand and quantify the ETEC disease burden, additional data are needed on the association between ETEC infection and physical and cognitive stunting as well as delayed educational attainment. Furthermore, the role of inappropriate or inadequate antibiotic treatment of ETEC-attributable diarrhoea may contribute to the development of antimicrobial resistance (AMR) and needs further elucidation. An ETEC vaccine that mitigates acute diarrhoeal illness and minimizes the longer-term disease manifestations could have significant public health impact and be a cost-effective countermeasure. Herein we review the ETEC vaccine pipeline, led by candidates compatible with the general parameters of the Preferred Product Characteristics (PPC) recently developed by the World Health Organization. Additionally, we have developed an ETEC Vaccine Development Strategy to provide a framework to underpin priority activities for researchers, funders and vaccine manufacturers, with the goal of addressing globally unmet data needs in the areas of research, product development, and policy, as well as commercialization and delivery. The strategy also aims to guide prioritization and co-ordination of the priority activities needed to minimize the timeline to licensure and use of ETEC vaccines, especially in in low- and middle-income countries, where they are most urgently needed.
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DOI：
10.1073/pnas.2014739117
发表时间：
2020-09-15
影响因子：
11.1
作者：
Ganguli A;Mostafa A;Berger J;Aydin MY;Sun F;Ramirez SAS;Valera E;Cunningham BT;King WP;Bashir R
通讯作者：
Bashir R
影响因子：
7.8
作者：
Harutyunyan S;Neuhauser I;Mayer A;Aichinger M;Szijártó V;Nagy G;Nagy E;Girardi P;Malinoski FJ;Henics T
通讯作者：
Henics T
影响因子：
3.8
作者：
Anderson, John D.;Muhib, Farzana;Wierzba, Thomas
通讯作者：
Wierzba, Thomas
影响因子：
3.1
作者：
Fleckenstein, JM;Roy, KS;Burkitt, M
通讯作者：
Burkitt, M
影响因子：
34.3
作者：
Anderson, John D.;Bagamian, Karoun H.;Rheingans, Richard
通讯作者：
Rheingans, Richard