How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella?

• Published in: Vaccine Vol. 37; no. 34; pp. 4778 - 4783
• Main Authors: Giersing, Birgitte K., Porter, Chad K., Kotloff, Karen, Neels, Pieter, Cravioto, Alejandro, MacLennan, Calman A.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 07.08.2019; Elsevier Limited
• Subjects: Age; Allergy and Immunology; Antigens; Antigens, Bacterial - chemistry; Antigens, Bacterial - immunology; Candidates; Challenge; Child; Cholera; Clinical Trials as Topic; Congresses as Topic; Development; Diarrhea - epidemiology; Diarrhea - immunology; Diarrhea - microbiology; Diarrhea - prevention & control; Dysentery, Bacillary - epidemiology; Dysentery, Bacillary - immunology; Dysentery, Bacillary - microbiology; Dysentery, Bacillary - prevention & control; enterotoxigenic Escherichia coli; FDA approval; Host-Pathogen Interactions - immunology; human diseases; Humans; Immunization - methods; Immunogenicity, Vaccine; Infectious diseases; issues and policy; Licenses; Licensure - ethics; Licensure - legislation & jurisprudence; Models, Immunological; Pathogenesis; Policy; Product development; Public health; Shigella; Shigella - drug effects; Shigella - immunology; Shigella - pathogenicity; Shigella Vaccines - administration & dosage; Shigella Vaccines - biosynthesis; stakeholders; Typhoid; Vaccine; Vaccines; Vaccines, Conjugate; Viruses; United States > US; Policy; Development; Vaccine; Shigella; Challenge
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2019.03.036

Controlled Human Infection Models (CHIMs) now exist for several infectious diseases. CHIMs offer significant insight into disease pathogenesis, as well the potential to rapidly test clinical proof-of-concept of vaccine candidates. The application of CHIMs to identify a correlate of protection that may reduce the sample size of, or obviate the need for clinical efficacy studies to achieve licensure is of considerable interest to vaccine developers and public health stakeholders. This topic was the subject of a workshop at the 2018 Vaccines Against Shigella and ETEC (VASE) conference, in the context of O-antigen-based Shigella vaccines.