Enterotoxigenic Escherichia coli (ETEC) and Shigella (ES) are the leading causes of moderate-to-severe diarrhea among children < 5 years of age in impoverished areas of the world. Recurrence of infection results in death, stunting, impaired cognitive development and long-term disability. Due to the huge impact of ES in children, vaccine development has been prioritized and accelerated in recent years. As promising vaccine candidates for ES move toward field trials in endemic areas, an improved understanding of the epidemiology of ES and identify the hotspots of these diseases are critical to plan Phase 3 trials and to assess the potential benefits of vaccine use. A critical constraint is the complex diagnostic methods currently required for detecting ES infections. These methods are neither sufficiently sensitive nor standardized and are not feasible in resource poor settings (RPS) where these infections are endemic. Therefore, the country-specific burden of ES is not readily available. Consequently regional public health officials and policy makers lack a clear appreciation of the impact that ES have on child health in their countries. Therefore, a diagnostic method which is sensitive, rapid and feasible for RPS is critically important and urgently required. Our recent work suggests that a direct detection from stool method LAMPES, is simple, easy to use and rapid. With limited training, we anticipate it can be carried out in basic laboratories and fields. Here we propose to evaluate the performance of our novel assay LAMPES and compare with the existing detection methods for ES using stool samples from children with and without diarrhea in an endemic setting, Kolkata, India. Given, this assay is rapid, sensitive, specific, easy to use, mostly equipment and electricity free, easy to scale up we believe LAMPES is an ideal tool to fill the gap in vaccine evaluation and ES disease surveillance in the endemic countries.

Public Health Relevance

Enterotoxigenic Escherichia coli (ETEC) and Shigella are the most common cause of diarrhea in the developing world, affecting millions of children. A key constraint in identifying the hot spots of ETEC and Shigella disease and evaluating the candidate vaccines is the lack of diagnostic methods which are sufficiently sensitive and suitable for resource poor settings where the disease generally occurs. This proposal will develop a novel, simple and rapid diagnostic method for ETEC and Shigella and will compare this new method with the current methods; thus, would facilitate the evaluation of candidate vaccines and surveillance of ETEC and Shigella diarrhea in the endemic countries.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AI137804-02
Application #
9751198
Study Section
Clinical Research and Field Studies of Infectious Diseases Study Section (CRFS)
Program Officer
Glock, Jonathan A
Project Start
2018-08-01
Project End
2020-07-31
Budget Start
2019-08-01
Budget End
2020-07-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205