The urgency to protect vulnerable populations such as the immunocompromised from viral respiratory diseases like influenza and 新型冠状病毒肺炎 is driving the need for novel approaches to new medicine development
To keep pace with the rapidly evolving variants of concern in the current pandemic and to be prepared for future pandemics, 需要快速的临床开发和批准途径来及时做出反应. One way that researchers and health authorities are expediting the process is through immunobridging trials, a scientific approach that has paved the way for vaccine approvals across numerous infectious diseases.1–4
什么是免疫桥接?
Immunobridging is an approach to a clinical trial used to infer effectiveness of a new drug or vaccine candidate through an accepted surrogate measure for efficacy.2
Immunobridging trials are designed to demonstrate equivalent activity for an investigational therapy to a similar existing therapy (control).2 One example is to compare the ability of an investigational therapy to neutralise current versions of a virus (the immune response) with the relevant immune response data for a control therapy that has clinical data showing it prevents or treats disease. “Bridging” the data allows researchers to extrapolate anticipated efficacy for the investigational therapy.
免疫桥接试验的优势是什么?
Immunobridging trials can help reduce development time and accelerate access to important new therapies, 不影响耐受性.5,6 Given the rapid evolution of many viruses such as 新型冠状病毒肺炎 and the need to quickly recruit trial patients, 收集数据并报告结果, immunobridging provides an important avenue to enable inference of protection while results are still clinically relevant.
什么时候使用免疫桥接试验?
Immunobridging trials are often used when full-scale efficacy trials may not be feasible or conducted under a fast enough timeline. This type of trial is well established for testing vaccines and has been used to develop and authorise 新型冠状病毒肺炎 booster shots, 每年流感疫苗更新, 人乳头瘤病毒和肺炎球菌疫苗.1–4
Immunobridging trials are also used to evaluate tolerability of the candidate therapeutic compared to the control. Health authorities and regulators agree that demonstrating tolerability of potential new products based on immunobridging is essential as well as the value in conducting post-marketing authorisation studies to further support safety profile and effectiveness.5,6
到目前为止，免疫桥接如何用于新型冠状病毒肺炎?
在新型冠状病毒肺炎, global medicines regulators support the need for immunobridging trials as effective forms of evidence of efficacy, to help meet the urgent need to provide vulnerable populations with protection in a rapidly evolving variant landscape.5,6
Evidence from studies with authorised vaccinations for 新型冠状病毒肺炎 was sufficient to support using neutralising antibody titers as a primary endpoint in cross-platform immunobridging trials.5
澳门第一赌城在线娱乐如何使用免疫桥接?
在澳门在线赌城娱乐, 澳门第一赌城在线娱乐致力于开发和提供变革性疫苗和抗体, 为疾病负担最重的数百万人提供长期免疫. 澳门第一赌城在线娱乐公司 is helping to lead the way with innovative immunobridging trials to accelerate access to next-generation medicines for 新型冠状病毒肺炎, where alternatives to running large efficacy trials are especially important given the rapid pace of viral evolution and the need to protect those at highest risk for severe disease.
We also work closely with global regulators and health authorities to agree upon the best and most efficient pathways and processes to support any potential authorisations of new therapies.
