Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Guwahati, India; Department of Biomedical Engineering, Indian Institute of Technology Ropar, Rupnagar Punjab, India.
Department of Pharmacology, Jamia Hamdard, New Delhi, India.
J Infect Public Health. 2022 May;15(5):515-525. doi: 10.1016/j.jiph.2022.03.017. Epub 2022 Mar 31.
About 270 million cases have been confirmed, and 5.3 million fatalities Worldwide due to SARS-CoV-2. Several vaccine candidates have entered phase 3 of the clinical trial and are being investigated to provide immunity to the maximum percentage of people. A safe and effective vaccine is required to tackle the current COVID-19 waves. There have been reports that clinical endpoints and psychological parameters are necessary to consider vaccine efficacy. This review examines the clinical endpoints required for a successful SARS-CoV-2 vaccine and the influences of psychological parameters on its efficacy.
The main research question was to find out the clinical endpoints that determine the vaccine efficacy? And what kind of psychological parameters affect the vaccine efficacy? The information was taken from several journals, databases, and scientific search engines like Googe scholar, Pubmed, Scopus, Web of Science, Science direct, WHO website, and other various sites. The research studies were searched using keywords; SAR-CoV-2 vaccine efficacy, psychological effect on SARS-CoV-2 vaccine, SARS-CoV-2 vaccine endpoints.
This review has highlighted various clinical endpoints that are the main determinants of clinical vaccine efficacy. Currently, vaccinations are being carried out throughout the world; it is important to investigate the main determinants affecting vaccine efficacy. We have focused on the clinical endpoints and the influence of psychological parameters that affect the vaccine efficacy in clinical settings. The primary endpoints include the risk of infection, symptoms, and severity of COVID-19, while hospitalization length, supplemental oxygen requirement, and mechanical ventilation are secondary endpoints in the clinical endpoints. Some tangential endpoints were also considered, including organ dysfunction, stroke, and MI. Many psychological associated things have influenced the vaccine efficacy, like the lower antibody titers in the vaccinated people. In addition to that, Short- and long-term stress and sleep deprivation were also found to affect the vaccine efficacy.
The review summarizes the important clinical endpoints required for a successful vaccine candidate. In addition to primary and secondary endpoints, auxiliary endpoints and the disease burden also play an important role in modulating vaccine efficacy. Moreover, the psychological perspective also influences vaccine efficacy. Effective follow-up of participants should follow to examine the clinical endpoints to reach any conclusion about vaccine efficacy.
全球范围内已确诊约 2.7 亿例病例，死亡 530 万例。目前已有多个候选疫苗进入临床试验 3 期，旨在为最大比例的人群提供免疫。需要安全有效的疫苗来应对当前的 COVID-19 浪潮。有报道称，临床终点和心理参数是评估疫苗效力所必需的。本综述旨在探讨成功的 SARS-CoV-2 疫苗所需的临床终点以及心理参数对其疗效的影响。
主要研究问题是找出确定疫苗疗效的临床终点？什么样的心理参数会影响疫苗的疗效？信息来自多个期刊、数据库以及谷歌学术、PubMed、Scopus、Web of Science、Science direct、WHO 网站和其他各种网站的科学搜索引擎。使用关键字搜索研究文献；SAR-CoV-2 疫苗效力、SARS-CoV-2 疫苗对心理的影响、SAR-CoV-2 疫苗终点。
本综述突出了作为临床疫苗疗效主要决定因素的各种临床终点。目前，全球正在开展疫苗接种工作；调查影响疫苗疗效的主要决定因素非常重要。我们专注于影响临床环境中疫苗疗效的临床终点和心理参数的影响。主要终点包括感染风险、COVID-19 症状和严重程度，而住院时间、补充氧气需求和机械通气是临床终点中的次要终点。还考虑了一些次要终点，包括器官功能障碍、中风和 MI。许多心理相关因素也影响了疫苗的疗效，例如接种人群中的抗体滴度较低。除此之外，短期和长期的压力和睡眠剥夺也被发现会影响疫苗的疗效。
本综述总结了成功的疫苗候选物所需的重要临床终点。除了主要和次要终点外，辅助终点和疾病负担在调节疫苗疗效方面也起着重要作用。此外，心理观点也会影响疫苗的疗效。应进行有效的随访，以检查临床终点，从而对疫苗的疗效得出任何结论。
