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Controlled Human Infection Model

CHIM studies involve intentional introduction of an infectious agent at a controlled dose by a specified route to healthy adult volunteers to evaluate the disease itself, its treatment, or the efficacy of candidate vaccines, among others. CHIM studies can lead to better understanding of the mechanism of infection, pathogenesis of disease, contributing host factors, microbial virulence, treatment protocols and vaccine induced responses; and can evaluate potential prophylactic vaccines.

Under current EU Clinical Trials Directive 2001/20 EC, a CHIM study only requires MHRA approval if it is a clinical trial of an investigational medicinal product. If no vaccine is involved in the study, MHRA approval is not necessary. However, all CHIM studies, regardless of protocol, must undergo ethical review and be approved by a IEC/IRB prior to the study. In contrast, the US-FDA require that studies are approved, through the Investigational New Drug application, and also that challenge agents are manufactured in compliance with GMP. In addition, ethical review by an IRB, is a requirement.