Clinical endpoints in the controlled human challenge model for Shigella: A call for standardization and the development of a disease severity score.

ABSTRACT: BACKGROUND:Since 1946 the controlled human infection model (CHIM) for Shigella has been used to improve understanding of disease pathogenesis, describe clinical and immunologic responses to infection and as a tool for vaccine development. As the frequency and intent for use in vaccine comparisons increases, standardization of the primary endpoint definition is necessary. METHODS:Subject-level data were obtained from previously conducted experimental Shigella CHIM studies. Signs and symptoms severity were categorized consistently across all studies. Sign and symptom correlations were estimated and univariate models were utilized to describe the association between stool output and other Shigella-attributable signs and symptoms. Multiple correspondence and hierarchical clustering analyses we

SUBMITTER: Porter CK 

PROVIDER: S-EPMC5874036 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature