Human infection studies: Key considerations for challenge agent development and production

Wellcome Open Research

article

Shobana Balasingam¹  Sarah Meillon¹  Cecilia Chui²  Alex Mann³  Carine La³  Charlotte L. Weller¹  Deborah F. King¹  Emma Smith⁴ 

[1] Infectious Diseases

[2]  Prevention;Clinical Sciences;Global Health Innovative Technology Fund;HIC-Vac, Imperial College London, National Heart & Lung Institute

关键词: human challenge study;    human infection study;    challenge agents;    GMP;    challenge agent production;   

DOI  :  10.12688/wellcomeopenres.17869.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Human infection (or challenge) studies involve the intentional administration of a pathogen (challenge agent) to volunteers. The selection, isolation, development and production of the challenge agent is one of the first steps in developing a challenge study and critical for minimising the risk to volunteers. Regulatory oversight for this production differs globally. Manufacturing agents within a Good Manufacturing Practice (GMP) facility reduces the risk of the manufacturing process by including processes such as confirming the identity of the challenge agent and ascertaining that it’s pure and free from impurities. However, in some cases it’s not possible or feasible to manufacture to GMP standards, for example where the challenge agent requires an intermediate vector for growth. There is lack of clear guidance on what the minimum requirements for high-quality safe manufacture outside of GMP facilities should be and here we describe the development of a considerations document for the selection and production of challenge agents to meet this need.

【 授权许可】

CC BY