Abstract
In recent years, controlled human infection models (CHIMs) have become available for a range of infectious agents and have proved invaluable for understanding the disease process, pathogenesis, and mechanisms of immunity. CHIM studies have also contributed significantly to advancing development of a number of vaccines by providing an indication of vaccine efficacy. The Shigella CHIM has been established in 3 sites in the United States, and it is likely that the CHIM will play an important regulatory role for advancing the range of Shigella vaccine candidates that are currently in development. This supplement describes the harmonization of best practices across sites, with a view to maximizing the contribution that CHIM studies can make to Shigella vaccine development.
Highlights
Controlled human infection models (CHIMs) involve the deliberate administration of a predetermined quantity of infectious agent to healthy human volunteers
Reanalysis of data from the Global Enteric Multicenter Study in low- and middle-income countries (LMICs) [12] using molecular diagnostics indicates that Shigella is the most attributable cause of moderate to severe diarrhea in children
There have been several issues identified with the potential utilization of the Shigella controlled human infection models (CHIMs), which have been reviewed previously [3] and include the variety of Shigella strains that might be required and the dose ranging of each of these strains; standardized challenge strains with expected diarrhea attack rates; the administration with or without buffer and specified buffering solutions; clinical endpoints for standardized evaluation across models; and clinical sampling and assay standardization
Summary
Controlled human infection models (CHIMs) involve the deliberate administration of a predetermined quantity of infectious agent to healthy human volunteers. The CHIM study had no clear primary clinical endpoint, thereby emphasizing the need for standardization of the model across sites. There have been several issues identified with the potential utilization of the Shigella CHIM, which have been reviewed previously [3] and include the variety of Shigella strains that might be required and the dose ranging of each of these strains; standardized challenge strains with expected diarrhea attack rates; the administration with or without buffer and specified buffering solutions; clinical endpoints for standardized evaluation across models; and clinical sampling and assay standardization.
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