重复剂量毒性研究是否有助于候选疫苗的安全性评估?疫苗开发人员调查。

IF 1.2 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Cynthia M Rohde, Eric Destexhe, Jan Willem van der Laan, Sarah Gould, Rachel Coe, Bert Haenen
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引用次数: 0

摘要

由生物安全公司发起的一项调查调查了疫苗公司(n = 12)如何看待重复剂量毒性研究在候选疫苗安全性评估中的价值。由于所有主要疫苗开发商都参与了调查,因此调查被认为代表了截至 2022 年的行业实践。疫苗开发商表示,他们认为对疫苗进行重复剂量毒性研究具有科学价值,尤其是在使用新型成分(如佐剂)或技术时。不过,也有少数公司(3/12)表示,重复剂量毒性研究可由带有额外毒性参数的药理学研究取代。对于大多数公司(9/12)来说,重复剂量毒性研究的结果从未阻止或推迟过首次人体试验(FIH)。其余 3 家公司共有 4 次推迟或阻止了临床开发,其中只有 2 次的研究结果被认为与疫苗有关。2016 年,流感疫苗已成功实施了平台方法,最新的传染病 mRNA-LNP 疫苗指南以及 FDA 提出的 COVID-19 疫苗开发和许可指南中都概述了平台方法的监管要求。疫苗开发商正在寻求将这一平台方法推广到新疫苗的开发中,在已有技术的基础上使用定义明确的生产工艺。这种方法有助于减少动物使用(3Rs 的一项原则),同时仍能保证这些产品的非临床安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Are Repeat-Dose Toxicity Studies Informative for Safety Assessment of Vaccine Candidates? A Survey of Vaccine Developers.

A BioSafe-sponsored survey investigated how vaccine companies (n = 12) perceive the value of the repeat-dose toxicity studies for safety assessment of vaccine candidates. As all major vaccine developers were part of the survey, it was considered representative for the industry practices up to 2022. Vaccine developers indicated that they see scientific value in performing repeat-dose toxicity studies with vaccines, especially when novel components (e.g., adjuvant) or technology is being used. However, a few (3/12) also indicated that repeat-dose toxicity studies could be replaced by a pharmacology study with additional toxicity parameters. For the majority of companies (9/12), findings from the repeat-dose toxicity studies never prevented or postponed a first-in-human (FIH) trial. In the remaining 3 companies, a total of 4 occurrences of postponement or prevention of clinical development occurred and in only 2 of these cases was the finding considered related to the vaccine. A platform approach has been successfully implemented for influenza vaccines already in 2016, and an outline of the regulatory requirements for a platform approach has been recently documented in the latest infectious disease mRNA-LNP vaccine guideline, as well as in the guidance on the development and licensure of COVID-19 vaccines presented by the FDA. Vaccine developers are seeking to extend this platform approach to the development of new vaccines, building on established technologies and using well-defined manufacturing processes. This approach could support reduction of animal use (a principle of 3Rs) while still providing reassurance of the nonclinical safety of these products.

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来源期刊
CiteScore
3.40
自引率
4.50%
发文量
53
审稿时长
4.5 months
期刊介绍: The International Journal of Toxicology publishes timely, peer-reviewed papers on current topics important to toxicologists. Six bi-monthly issues cover a wide range of topics, including contemporary issues in toxicology, safety assessments, novel approaches to toxicological testing, mechanisms of toxicity, biomarkers, and risk assessment. The Journal also publishes invited reviews on contemporary topics, and features articles based on symposia. In addition, supplemental issues are routinely published on various special topics, including three supplements devoted to contributions from the Cosmetic Review Expert Panel.
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