Vinusha Vijayakumar, Girish Chandrashekaran
Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, 605 006, India.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Jan;398(1):363-377. doi: 10.1007/s00210-024-03368-1. Epub 2024 Aug 23.
This paper reviews the importance of vaccine trials to public health. Vaccines are developed to build immunity to disease, which have helped to completely eliminate smallpox, and reduced incidence of polio and measles. A variety of breakthroughs made many years ago, such as the smallpox vaccine by Edward Jenner and the discoveries by Louis Pasteur, also set the stage for modern international immunization programs. A few events, such as the licensing of the polio vaccine and the passage of the Vaccination Assistance Act helped to improve the study of vaccines. In particular, vaccine trials may be RCTs, cluster trials, or cohort studies. The sample sizes will depend on the objectives, which would include the primary and secondary endpoints. The population under study and the geographical location also affect the trial design. Preclinical evaluation is usually the starting point of vaccine trials, where the safety and efficacy are researched on animal models or cell cultures. Animal models are selected based on their similarity to the target disease. Safety is checked in Phase I, efficacy in Phase II, and both in Phase III. Phase IV is a post-marketing surveillance of the vaccine's safety in real life. Regulatory bodies play a very vital role in ensuring that vaccines adhere to a very high standard of safety and efficacy, such as the FDA, as required. Ethical considerations, such as informed consent and the rights of participants, are innate and are implemented and enforced through laws, regulations, and ethical committees. Vaccine studies vary from the drug studies as it is focused on preventing illness in healthy patients as opposed to cure of diseases in drug trials. The dramatic development in vaccine research was driven by recent pandemics, with parallel processing and data collection in real time. Clinical trials of the vaccine are a foundation stone of public health in the reduction of sickness, offering immunity to diseases, and continuing the fight against infectious diseases. The present review is aimed at describing vaccine trials and their important aspects.
本文综述了疫苗试验对公共卫生的重要性。疫苗的研发旨在建立对疾病的免疫力，这有助于彻底消灭天花，并降低脊髓灰质炎和麻疹的发病率。多年前取得的一系列突破，如爱德华·詹纳的天花疫苗和路易斯·巴斯德的发现，也为现代国际免疫计划奠定了基础。一些事件，如脊髓灰质炎疫苗的许可和《疫苗援助法案》的通过，有助于改进疫苗研究。特别是，疫苗试验可能是随机对照试验、整群试验或队列研究。样本量将取决于目标，其中包括主要和次要终点。所研究的人群和地理位置也会影响试验设计。临床前评估通常是疫苗试验的起点，在动物模型或细胞培养中研究安全性和有效性。根据与目标疾病的相似性选择动物模型。在I期检查安全性，在II期检查有效性，在III期同时检查安全性和有效性。IV期是疫苗在现实生活中的上市后安全性监测。监管机构在确保疫苗符合非常高的安全性和有效性标准方面发挥着至关重要的作用，如美国食品药品监督管理局（FDA）所要求的那样。伦理考量，如知情同意和参与者的权利，是固有的，并通过法律、法规和伦理委员会来实施和执行。疫苗研究与药物研究不同，因为它专注于预防健康患者的疾病，而药物试验则是治疗疾病。近期的大流行推动了疫苗研究的显著发展，同时进行实时数据处理和收集。疫苗临床试验是公共卫生在减少疾病、提供疾病免疫力以及持续抗击传染病方面的基石。本综述旨在描述疫苗试验及其重要方面。
