Exploratory clinical studies in general, and controlled human infection models (CHIM) in particular, have the potential to rapidly advance the development of global health vaccines. CHIM for pathogens of public health importance have been used for more than 70 years to examine the pathogenesis, clinical features, microbiology, and the immune response to various infectious agents. In a CHIM study, a selected strain of a pathogen is administered to healthy adult volunteers at a defined dose and by a specific route of administration. Volunteers are cared for and closely monitored for evidence of infection and the symptoms of disease that develop. The pathogen is cleared from volunteers prior to study completion.
CHIM are currently available for a range of enteric, respiratory, and vector-borne diseases, and have played a key role in the development of some of the vaccines we use today. The wider use of CHIM could further accelerate development of candidate vaccines, in part by the early elimination of some candidate vaccines while advancing others to field efficacy trials. CHIM studies are also an important source of information about immune responses to infection and vaccination.
CHIM research requires appropriate facilities and specialized investigator expertise, and clinical capacity is limited. The CHIM Consortium is a network of clinical research sites and investigators skilled in the conduct of CHIM, with centralized support and coordination through PATH and The Emmes Corporation. As a platform technology within the Global Health Vaccine Accelerator Program (GH-VAP), the CHIM Consortium will provide opportunities for greater integration of the immune monitoring technologies available through the GH-VAP into CHIM studies.