Consensus Report on Shigella Controlled Human Infection Model: Conduct of Studies

Kawsar R. Talaat, A. Louis Bourgeois, Robert W. Frenck, Wilbur H. Chen, Calman A. Maclennan, Mark S. Riddle, Akamol E. Suvarnapunya, Jessica L. Brubaker, Karen L. Kotloff, Chad K. Porter

Research output: Contribution to journalArticle

Abstract

Shigella causes morbidity and mortality worldwide, primarily affecting young children living in low-resource settings. It is also of great concern due to increasing antibiotic resistance, and is a priority organism for the World Health Organization. A Shigella vaccine would decrease the morbidity and mortality associated with shigellosis, improve child health, and decrease the need for antibiotics. Controlled human infection models (CHIMs) are useful tools in vaccine evaluation for early up- or down-selection of vaccine candidates and potentially useful in support of licensure. Over time, the methods employed in these models have become more uniform across sites performing CHIM trials, although some differences in conduct persist. In November 2017, a Shigella CHIM workshop was convened in Washington, District of Columbia. Investigators met to discuss multiple aspects of these studies, including study procedures, clinical and immunological endpoints, and shared experiences. This article serves as a uniform procedure by which to conduct Shigella CHIM studies.

Original languageEnglish (US)
Pages (from-to)S580-S590
JournalClinical Infectious Diseases
Volume69
DOIs
StatePublished - Dec 9 2019

Keywords

  • Shigella
  • challenge studies
  • controlled human infection model
  • human infection studies
  • methods

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Talaat, K. R., Bourgeois, A. L., Frenck, R. W., Chen, W. H., Maclennan, C. A., Riddle, M. S., Suvarnapunya, A. E., Brubaker, J. L., Kotloff, K. L., & Porter, C. K. (2019). Consensus Report on Shigella Controlled Human Infection Model: Conduct of Studies. Clinical Infectious Diseases, 69, S580-S590. https://doi.org/10.1093/cid/ciz892