Twine Susan M, Fulton Kelly M, Spika John, Ouellette Marc, Raven Jennifer F, Conlan J Wayne, Krishnan Lakshmi, Barreto Luis, Richards James C
a National Research Council Canada-Human Health Therapeutics (NRC-HHT) ; Ottawa , Ontario , Canada.
b Public Health Agency of Canada (PHAC) ; Ottawa , Ontario , Canada.
Hum Vaccin Immunother. 2015;11(12):2923-30. doi: 10.1080/21645515.2015.1083663.
Vaccine biomarkers are critical to many aspects of vaccine development and licensure, including bridging findings in pre-clinical studies to clinical studies, predicting potential adverse events, and predicting vaccine efficacy. Despite advances in our understanding of various biological pathways, and advances in systems analyses of the immune response, there remains much to learn about qualitative and quantitative aspects of the human host response to vaccination. To stimulate discussion and identify opportunities for collaborative ways to advance the field of vaccine biomarkers, A Next Generation Vaccine Biomarker workshop was held in Ottawa. The two day workshop, sponsored by the National Research Council Canada, Canadian Institutes of Health Research, Public Health Agency of Canada, Pfizer, and Medicago, brought together stakeholders from Canadian and international industry, government and academia. The workshop was grouped in themes, covering vaccine biomarker challenges in the pre-clinical and clinical spaces, veterinary vaccines, regulatory challenges, and development of biomarkers for adjuvants and cancer vaccines. The use of case studies allowed participants to identify the needs and gaps requiring innovation. The workshop concluded with a discussion on opportunities for vaccine biomarker discovery, the Canadian context, and approaches for moving forward. This article provides a synopsis of these discussions and identifies steps forward for advancing vaccine biomarker research in Canada.
疫苗生物标志物在疫苗研发和许可的诸多方面都至关重要,包括将临床前研究结果与临床研究相衔接、预测潜在不良事件以及预测疫苗效力。尽管我们对各种生物学途径的理解有所进展,且免疫反应的系统分析也取得了进步,但在人类宿主对疫苗接种反应的定性和定量方面仍有许多有待了解之处。为了激发讨论并确定推进疫苗生物标志物领域的合作方式,一场下一代疫苗生物标志物研讨会在渥太华举行。为期两天的研讨会由加拿大国家研究委员会、加拿大卫生研究院、加拿大公共卫生局、辉瑞公司和 Medicago 公司赞助,汇聚了来自加拿大和国际行业、政府及学术界的利益相关者。研讨会按主题分组,涵盖临床前和临床领域的疫苗生物标志物挑战、兽用疫苗、监管挑战以及佐剂和癌症疫苗生物标志物的开发。通过案例研究,参与者能够确定需要创新的需求和差距。研讨会最后讨论了疫苗生物标志物发现的机会、加拿大的背景情况以及未来的推进方法。本文概述了这些讨论内容,并确定了在加拿大推进疫苗生物标志物研究的下一步措施。