Toxicologic Pathology Forum: Tissue Evaluation in Nonclinical Toxicity Studies for Prophylactic Vaccines.

IF 1.4 4区 医学 Q3 PATHOLOGY
Toxicologic Pathology Pub Date : 2023-01-01 Epub Date: 2023-04-21 DOI:10.1177/01926233231163474
Rani S Sellers
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引用次数: 0

Abstract

Nonclinical toxicity testing (GLP) of prophylactic vaccines to support human clinical trials is outlined in the World Health Organization nonclinical vaccine-development guidelines, which are followed by most regulatory agencies globally. Vaccine GLP toxicity studies include at least two groups: a buffer control (often phosphate-buffered saline) group and a highest anticipated clinical dose formulation group. However, studies may include additional groups, including lower-dose formulation groups and adjuvant-containing formulation control groups. World Health Organization guidelines touch upon expectations for dose group and tissue selection for microscopic evaluation, but there is variation in the interpretation of this aspect of these guidelines between vaccine developers. This opinion piece proposes a scientifically based approach for defining appropriate groups to evaluate in the dosing and recovery phases in nonclinical vaccine toxicity studies, as well as suggestions on selecting tissues for microscopic evaluation at the recovery phase of studies to promote alignment between vaccine manufacturers.

Abstract Image

毒理病理学论坛:预防性疫苗非临床毒性研究中的组织评估。
世界卫生组织非临床疫苗开发指南概述了预防性疫苗的非临床毒性测试 (GLP),以支持人体临床试验,全球大多数监管机构都遵循该指南。疫苗 GLP 毒性研究至少包括两组:缓冲对照组(通常为磷酸盐缓冲盐水)和最高预期临床剂量配方组。不过,研究也可能包括更多的组别,包括低剂量制剂组和含佐剂制剂对照组。世界卫生组织的指导方针涉及剂量组和显微镜评估组织选择的预期,但不同疫苗开发商对这些指导方针在这方面的解释存在差异。本意见书提出了一种以科学为基础的方法,用于定义非临床疫苗毒性研究中剂量和恢复阶段的适当评估组,以及在研究的恢复阶段选择组织进行显微评估的建议,以促进疫苗生产商之间的协调。
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来源期刊
Toxicologic Pathology
Toxicologic Pathology 医学-病理学
CiteScore
4.70
自引率
20.00%
发文量
57
审稿时长
6-12 weeks
期刊介绍: Toxicologic Pathology is dedicated to the promotion of human, animal, and environmental health through the dissemination of knowledge, techniques, and guidelines to enhance the understanding and practice of toxicologic pathology. Toxicologic Pathology, the official journal of the Society of Toxicologic Pathology, will publish Original Research Articles, Symposium Articles, Review Articles, Meeting Reports, New Techniques, and Position Papers that are relevant to toxicologic pathology.
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