SMART PRACTICES FOR PRODUCTION OF CHALLENGE AGENTS

Human Infection Studies (also known as Controlled Human Infection Studies/Models or Challenge studies) are defined as biomedical research whereby volunteers are intentionally exposed to viable infectious agents (challenge agents) under carefully controlled conditions to further understanding of different diseases, infectious processes and human immune responses.

The Smart Practices are a summary of the “Considerations on the principles of development and manufacturing qualities of challenge agents for use in human infection models” (2022); a document developed by a consortium of international experts to discuss fundamental principles of selection, characterisation, manufacture, quality control and storage of challenge agents for international reference. They do not form regulatory guidelines or guidance but reflect the consortium’s recommendations in the absence of clear regulatory guidance.