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The way forward for ETEC controlled human infection models (CHIMs).
Kurt Hanevik1, Wilbur H Chen2, Kawsar R Talaat3
1Norwegian National Advisory Unit on Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Vaccine
|February 3, 2019
Summary
Controlled Human Infection Models (CHIMs) are crucial for developing vaccines against Enterotoxic Escherichia coli (ETEC). Standardizing ETEC CHIMs and developing new challenge strains are priorities for advancing vaccine and therapeutic development.
Area of Science:
- Infectious Diseases
- Vaccinology
- Microbiology
Background:
- Controlled Human Infection Models (CHIMs) are vital for evaluating vaccine efficacy against Enterotoxic Escherichia coli (ETEC) in the absence of suitable animal models.
- The 2018 Vaccines Against Shigella and ETEC (VASE) conference convened experts to discuss advancements and standardization of ETEC CHIMs.
Purpose of the Study:
- To review and discuss new developments in ETEC challenge models and key issues for standardization.
- To identify needs for diverse ETEC strains, standardized CHIM protocols, volunteer screening, and sample collection for immune response analysis.
Main Methods:
- A workshop format with invited speakers and breakout group discussions.
- Focused discussions on ETEC strain selection, CHIM standardization, volunteer criteria, and immune response assessment.
Main Results:
- Agreement on the need for additional ETEC challenge strains, particularly a well-characterized ST-only expressing strain, to support new vaccine candidates.
- Strong encouragement for further standardization of ETEC CHIMs, acknowledging potential limitations in universal standardization across all strains.
- Proposal for an intensified volunteer screening schedule and a defined sampling plan to enhance immune response analysis and understanding of pathogenesis.
Conclusions:
- Additional ETEC challenge strains are necessary to advance vaccine and therapeutic development pipelines.
- Standardization of ETEC CHIMs is crucial, with a focus on specific strain characteristics and realistic implementation.
- Optimized volunteer selection and comprehensive sample collection are essential for deeper insights into ETEC infection, pathogenesis, and correlates of protection.
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