# An Expanded Multivalent Vaccine to Prevent MDR Shigella and ETEC Disease

> **NIH NIH U19** · UNIVERSITY OF MARYLAND BALTIMORE · 2020 · $775,033

## Abstract

The goal of this proposal is to construct a vaccine that is broadly protective against the epidemiologically most
important Shigella serotypes and toxin and colonization factor types of enterotoxigenic E. coli (ETEC), two
enteropathogens of substantial public health importance to the U.S. and global populations. Both pathogens are
designated serious threats by the Centers for Disease Control (CDC) in the U.S. due to increasing multidrug
resistance leading to fewer options for therapeutic intervention. Shigella and ETEC readily acquire antimicrobial
resistance mechanisms and additional virulence factors, making these pathogens important emerging threats.
An oral vaccine with broad coverage against the most prevalent circulating isolates would be beneficial to multiple
populations, including: 1) adult and child travelers who visit less developed countries where these infections are
hyperendemic; 2) children and adults in certain high risk populations in the US; 3) children < age 5 years in
developing countries, and 4) for mass immunization to control natural or deliberate outbreaks. The vaccine will
consist of a mixed inoculum of 6 live attenuated strains of Shigella expressing ETEC colonization factor antigens
and antigens to induce toxin neutralizing antibodies against heat labile (LT) and heat stable (ST) toxins. Oral
immunization is an effective method for inducing mucosal as well as systemic immune responses believed to be
important in protection against these enteropathogens and oral delivery is a practical route for product
deployment and for enhancing compliance. We are taking advantage of the successful completion of five
attenuated Shigella vaccine strains expressing heterologous antigens during the previous CETR funding period,
and using current epidemiological data, as well as novel technological advances, to improve and broaden the
vaccine formulation in order to maximize the protective efficacy of this Shigella-ETEC vaccine product and
optimize features for production. Our specific objective is to complete vaccine candidate optimization and pre-
clinical evaluation to enable IND submission for advancement to clinical trials. This project relates directly to the
overarching goal of this Program to develop active vaccination and passive antibody strategies to prevent
disease caused by multidrug-resistant bacterial pathogens. The collective expertise provided by CETR project
investigators and collaborating scientists along with the Center for Vaccine Development's experience in
translating products through manufacture and clinical evaluation, will accelerate efforts to advance vaccine
development.

## Key facts

- **NIH application ID:** 9893803
- **Project number:** 5U19AI142725-02
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Eileen M. Barry
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $775,033
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9893803

## Citation

> US National Institutes of Health, RePORTER application 9893803, An Expanded Multivalent Vaccine to Prevent MDR Shigella and ETEC Disease (5U19AI142725-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9893803. Licensed CC0.

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