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Published on: February 27, 2019
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Consensus Report on Shigella Controlled Human Infection Model: Immunological Assays.
Robert W Kaminski1, Marcela F Pasetti2, Ana Older Aguilar3
1Subunit Enteric Vaccines and Immunology, Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring.
Summary
Developing a standardized enzyme-linked immunosorbent assay (ELISA) for Shigella lipopolysaccharide (LPS) antibodies is crucial for advancing vaccine development and deployment. This harmonized approach will enable better comparisons across clinical studies and accelerate Shigella vaccine licensure.
Area of Science:
- Infectious Diseases
- Vaccinology
- Immunology
Background:
- Shigella infections cause significant childhood morbidity and mortality globally, particularly in low- and middle-income countries.
- Antimicrobial resistance and treatment limitations highlight the need for effective Shigella vaccines.
- Controlled human infection models (CHIMs) are valuable for vaccine efficacy assessment but lack standardized immunological analysis.
Purpose of the Study:
- To establish consensus guidelines for immunological assays in Shigella CHIM studies.
- To develop a harmonized enzyme-linked immunosorbent assay (ELISA) for quantifying serum immunoglobulin G (IgG) antibodies against Shigella lipopolysaccharide (LPS).
- To facilitate international collaboration for standardizing Shigella vaccine development and licensure.
Main Methods:
- Review of existing Shigella CHIM studies by an expert working group.
- Prioritization of immunoassays, specimens, and collection time points, ranking antibodies to Shigella LPS as highest priority.
- Workshop focused on developing a standardized ELISA for Shigella LPS-specific IgG titers.
Main Results:
- Consensus reached on prioritizing antibodies to Shigella LPS.
- Agreement to establish an international consortium to develop a harmonized ELISA.
- Plans to produce reference sera and identify a reliable source of Shigella LPS.
Conclusions:
- Standardized immunological procedures, particularly a harmonized ELISA for Shigella LPS antibodies, are essential for comparing clinical trial data.
- This standardization will accelerate Shigella vaccine development, support licensure, and facilitate global vaccine deployment and uptake.
- Collaborative efforts are underway to create common procedures for advancing Shigella vaccine research.
