Cox A D, Barreto L, Ulanova M, Bruce M G, Tsang Rsw
Human Health Therapeutics Portfolio, National Research Council, Ottawa, ON.
Northern Ontario School of Medicine, Lakehead University, Thunder Bay, ON.
Can Commun Dis Rep. 2017 May 4;43(5):89-95. doi: 10.14745/ccdr.v43i05a02.
Since the late 1990s there has been an emergence of serotype a (Hia) infections, especially in Indigenous communities in the northern regions of Canada and Alaska associated with significant morbidity and approximately a 10% mortality. A Hia vaccine could potentially prevent this disease and save the health care system millions of dollars in both acute and long-term care. On March 23-24, 2016, the National Research Council (NRC), the Public Health Agency of Canada (PHAC) and the Canadian Institutes of Health Research (CIHR) co-organized a meeting on serotype a (Hia) to examine the current state of disease epidemiology and a potential vaccine solution path. The meeting included representatives from academia, federal and territorial public health units, hospital laboratories, federal departments involved in Aboriginal health, advocacy organizations for Indigenous peoples and industry. Representatives from industry confirmed having the capacity and the interest to support preparation of clinical trial batches. Canadian regulatory authorities have expressed a willingness to help ensure appropriate measures are in place for licensure purposes. Furthermore, there is the capacity and interest in performing some clinical trials in Indigenous communities in both Canada and Alaska. Recommendations for next steps included: complete pre-clinical studies, improve epidemiological surveillance to better understand the extent of the disease in the rest of North America and globally, establish engagement mechanisms with national Indigenous organizations to ensure their peoples are fully involved in the process and explore funding opportunities to prepare clinical lots and undertake clinical trials.
自20世纪90年代末以来,血清型a(Hia)感染开始出现,尤其是在加拿大北部地区和阿拉斯加的原住民社区,这些感染与显著的发病率以及约10%的死亡率相关。一种Hia疫苗有可能预防这种疾病,并为医疗保健系统在急性和长期护理方面节省数百万美元。2016年3月23日至24日,国家研究委员会(NRC)、加拿大公共卫生署(PHAC)和加拿大卫生研究院(CIHR)共同组织了一次关于血清型a(Hia)的会议,以审查疾病流行病学的现状和潜在的疫苗解决方案路径。会议邀请了学术界、联邦和地区公共卫生单位、医院实验室、参与原住民健康事务的联邦部门、原住民权益倡导组织以及企业的代表。企业代表确认有能力且有兴趣支持临床试验批次的制备。加拿大监管当局表示愿意协助确保为许可目的采取适当措施。此外,在加拿大和阿拉斯加的原住民社区开展一些临床试验既有能力也有兴趣。下一步的建议包括:完成临床前研究,加强流行病学监测以更好地了解北美其他地区和全球的疾病范围,建立与全国原住民组织的参与机制以确保其民众充分参与该过程,并探索资金机会以制备临床批次并开展临床试验。