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Clin Infect Dis. 2019 Dec 9;69(Supplement_8):S580-S590. doi: 10.1093/cid/ciz892.

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

Author information

1
Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
2
Enteric Vaccine Initiative, PATH, Washington, District of Columbia.
3
Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
4
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.
5
Bill & Melinda Gates Foundation, London, United Kingdom.
6
F. Edward Hébert School of Medicine, Uniformed Services University, Bethesda.
7
Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring.
8
Global Disease Epidemiology and Control Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health.
9
Division of Infectious Disease and Tropical Pediatrics, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.
10
Enteric Disease Department, Naval Medical Research Center, Silver Spring, Maryland.

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.

KEYWORDS:

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

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