How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella?
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 m...
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| Published in | Vaccine Vol. 37; no. 34; pp. 4778 - 4783 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
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Netherlands
Elsevier Ltd
07.08.2019
Elsevier Limited |
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| Abstract | 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. |
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| AbstractList | 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. AbstractControlled 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. 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.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. |
| Author | Porter, Chad K. Cravioto, Alejandro Neels, Pieter Kotloff, Karen MacLennan, Calman A. Giersing, Birgitte K. |
| Author_xml | – sequence: 1 givenname: Birgitte K. orcidid: 0000-0003-2555-7756 surname: Giersing fullname: Giersing, Birgitte K. email: giersingb@who.int organization: Initiative for Vaccine Research, Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland – sequence: 2 givenname: Chad K. surname: Porter fullname: Porter, Chad K. organization: Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA – sequence: 3 givenname: Karen surname: Kotloff fullname: Kotloff, Karen organization: Department of Pediatrics and Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA – sequence: 4 givenname: Pieter surname: Neels fullname: Neels, Pieter organization: International Alliance for Biological Standardization, Geneva, Switzerland – sequence: 5 givenname: Alejandro surname: Cravioto fullname: Cravioto, Alejandro organization: Facultad de Medicina, Universidad Nacional Autónoma de México, Ciudad de México, Mexico – sequence: 6 givenname: Calman A. surname: MacLennan fullname: MacLennan, Calman A. organization: Enteric & Diarrheal Diseases, Global Health, Bill & Melinda Gates Foundation, Seattle, WA, USA |
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| Snippet | Controlled Human Infection Models (CHIMs) now exist for several infectious diseases. CHIMs offer significant insight into disease pathogenesis, as well the... AbstractControlled Human Infection Models (CHIMs) now exist for several infectious diseases. CHIMs offer significant insight into disease pathogenesis, as well... |
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| SubjectTerms | 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 |
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| Title | How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella? |
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