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Cited by 130Ethics in Clinical ResearchBacterial Infections and VaccinesSARS-CoV-2 and COVID-19 Research

Design, recruitment, and microbiological considerations in human challenge studies

Darton, Thomas C, Blohmke, Christoph J, Moorthy, Vasee S, Altmann, Daniel M, Hayden, Frederick G, Clutterbuck, Elizabeth A, Levine, Myron M, Hill, Adrian V S +1 more·2015·The Lancet Infectious Diseases
DOI 10.1016/s1473-3099(15)00068-7
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Abstract

Since the 18th century a wealth of knowledge regarding infectious disease pathogenesis, prevention, and treatment has been accumulated from findings of infection challenges in human beings. Partly because of improvements to ethical and regulatory guidance, human challenge studies-involving the deliberate exposure of participants to infectious substances-have had a resurgence in popularity in the past few years, in particular for the assessment of vaccines. To provide an overview of the potential use of challenge models, we present historical reports and contemporary views from experts in this type of research. A range of challenge models and practical approaches to generate important data exist and are used to expedite vaccine and therapeutic development and to support public health modelling and interventions. Although human challenge studies provide a unique opportunity to address complex research questions, participant and investigator safety is paramount. To increase the collaborative effort and future success of this area of research, we recommend the development of consensus frameworks and sharing of best practices between investigators. Furthermore, standardisation of challenge procedures and regulatory guidance will help with the feasibility for using challenge models in clinical testing of new disease intervention strategies.

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Crossref · 10.1016/s1473-3099(15)00068-7

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  • Human challenge studies have been used to demonstrate the role of antibodies in protection against malaria and typhoid.

    “human challenge studies offer the opportunity to efficiently assess correlates of protection (Box 2) under controlled circumstances36, and they have been used to demonstrate the role of antibodies in protection against malaria37 and typhoid38.”

    From A guide to vaccinology: from basic principles to new developments (2021) · cites this paper as [36]

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Authors
Darton, T. C., Blohmke, C. J., Moorthy, V. S., Altmann, D. M., Hayden, F. G., Clutterbuck, E. A., Levine, M. M., Hill, A. V. S., & Pollard, A. J.
Affiliations
  • University of Oxford (GB)
  • World Health Organization (CH)
  • Imperial College London (GB)
  • University of Virginia (US)
  • University of Maryland, Baltimore (US)
Corresponding author
Blohmke, Christoph J
ORCID
Venue
The Lancet Infectious Diseases
Publisher
Elsevier BV
Published
2015-07
Volume
15
Issue
7
Pages
840-851
ISSN
1473-3099 (ISSN-L)
DOI
10.1016/s1473-3099(15)00068-7
OpenAlex
W2150527785
Cited by
130
References
127
Citations by year
2026: 6 · 2025: 11 · 2024: 7 · 2023: 10 · 2022: 12 · 2021: 12 · 2020: 27 · 2019: 14 · 2018: 14 · 2017: 7 · 2016: 9 · 2015: 1
FWCI
1.49
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Infectious Diseases (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • World Health Organization
  • Wellcome Trust (092661)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Keywords
human challenge studies, vaccine evaluation, infectious disease pathogenesis, participant safety, research ethics, regulatory guidelines, best practices, consensus framework, treatment development
MeSH terms
Anti-Infective Agents, Communicable Disease Control, Communicable Diseases, Humans, Human Experimentation, Research Design, Safety, Vaccines, Guidelines as Topic, Biomedical Research, Drug Discovery

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