Manchester Cancer Research Centre, University of Manchester, UK.
Ann Allergy Asthma Immunol. 2020 Jul;125(1):17-27. doi: 10.1016/j.anai.2020.01.025. Epub 2020 Feb 7.
The goal of a vaccine is to prime the immune response so the immune memory can facilitate a rapid response to adequately control the pathogen on natural infection and prevent disease manifestation. This article reviews the main elements that provide for the development of safe and effective vaccines.
Literature covering target pathogen epidemiology, the key aspects of the functioning immune response underwriting target antigen selection, optimal vaccine formulation, preclinical and clinical trial studies necessary to deliver safe and efficacious immunization.
Whole live, inactivated, attenuated, or partial fractionated organism-based vaccines are discussed in respect of the balance of reactogenicity and immunogenicity. The use of adjuvants to compensate for reduced immunogenicity is described. The requirements from preclinical studies, including establishing a proof of principle in animal models, the design of clinical trials with healthy volunteers that lead to licensure and beyond are reviewed.
The 3 vaccine development phases, preclinical, clinical, and post-licensure, integrate the requirements to ensure safety, immunogenicity, and efficacy in the final licensed product. Continuing monitoring of efficacy and safety in the immunized populations is essential to sustain confidence in vaccination programs.
In an era of increasing vaccine hesitancy, the need for a better and widespread understanding of how immunization acts to counteract the continuing and changing risks from the pathogenic world is required. This demands a societal responsibility for obligate education on the benefits of vaccination, which as a medical intervention has saved more lives than any other procedure.
疫苗的目标是启动免疫反应，以便免疫记忆能够促进对病原体的快速反应，从而充分控制病原体并预防疾病发生。本文综述了确保安全有效的疫苗开发的主要要素。
涵盖目标病原体流行病学、支撑目标抗原选择的免疫反应关键方面、最佳疫苗配方、进行临床前和临床试验以提供安全有效的免疫接种的文献。
讨论了全活、灭活、减毒或部分分馏的基于生物体的疫苗，以平衡其致反应性和免疫原性。描述了使用佐剂来补偿免疫原性降低的情况。综述了临床前研究的要求，包括在动物模型中建立原理验证、设计有健康志愿者参与的临床试验以获得许可及以后的研究。
疫苗开发的三个阶段，临床前、临床和上市后，整合了确保最终上市产品安全性、免疫原性和疗效的要求。继续监测免疫人群中的疗效和安全性对于维持对疫苗接种计划的信心至关重要。
在疫苗犹豫情绪日益加剧的时代，需要更好地、更广泛地了解免疫接种如何对抗来自致病世界的持续变化的风险。这需要社会有责任对疫苗接种的益处进行强制性教育，作为一种医疗干预措施，它挽救的生命比任何其他程序都多。
