BALTIMORE, MD, . Dec 10 — Each year, millions of people contract serious diarrheal illnesses typically from contaminated food and water. Among the biggest causes of diarrheal diseases are the bacteria Shigella and enterotoxigenic Escherichia coli (ETEC), and researchers at the University of Maryland School of Medicine are testing a vaccine designed to offer protection against these serious pathogens.
Wilbur Chen, MD, MS, Associate Professor of Medicine, is Principal Investigator, and Eileen Barry, PhD, Professor of Medicine, is co-Principal Investigator for this research, which is being funded by a $4.5 million agreement with Emergent BioSolutions, a global life sciences company focused on addressing public health threats, including travel health diseases.
Drs. Chen and Barry will conduct early clinical trials of a combined Shigella-ETEC vaccine called “CVD 1208S-122,” a vaccine comprised of a weakened live strain of Shigella expressing protective antigens from ETEC that was developed at UMSOM’s Center for Vaccine Development and Global Health (CVD).
Their research will test the safety, tolerability and potential protection of oral doses of the prototype Shigella-ETEC vaccine. The trials will include testing how the immune system in healthy adults responds to varying doses of the vaccine. The goal is to determine the safety and best dosing of the vaccine, which could ultimately protect millions of people around the world who are at most risk to diarrheal diseases.
“Our goal here is to develop a vaccine that can be delivered broadly to those who are most susceptible to the risks of these diseases,” said Dr. Chen. “This is something that can help serve the most vulnerable populations in low resource settings in sub-Sahara Africa and South Asia, where the disease burden is highest.”
Development of the vaccine has been years in the making. Ultimately, it will be comprised of several weakened strains of Shigella, expressing a wide array of ETEC antigens, enabling the body’s immune system to generate antibodies and cellular protection against these diarrheal pathogens. Researchers at CVD, including Dr. Barry, have been constructing optimized vaccine components and analyzing their performance in preclinical studies to develop the best form of protection. Development of additional vaccine components will be supported by this partnership with Emergent.
Development of this vaccine was based on epidemiologic studies that identified the most important strains and antigens associated with disease and included extensive genome analysis and pre-clinical testing,” said Dr. Barry. According to the World Health Organization (WHO), Shigella and ETEC are two of the leading causes of diarrhea worldwide. It is estimated that these two bacteria alone are responsible for more than 15 percent of the approximately 500,000 deaths among children under the age of five.
“One of the ways Emergent furthers its mission – to protect and enhance life – is to invest in scientific research and development by organizations that are aligned with our focus on improving public health,” said Kelly Lyn Warfield, PhD, VP, Vaccines Research and Development at Emergent BioSolutions. “As a leader in emerging infectious diseases and travel health vaccines, we are pleased to partner with USOM to advance a potential vaccine to protect against Shigella and ETEC, two leading causes of diarrhea worldwide.”
In addition to the risk of child mortality, CVD research has shown that repeated infections and episodes of diarrheal diseases can lead to stunted growth in young children and impaired physical and cognitive development. Individuals typically contract Shigella and ETEC infection by ingesting contaminated food and water, but these illnesses can also be contracted through close direct contact with others who are infected.
“We know that diarrheal diseases are a leading cause of mortality for children. This research at the Center for Vaccine Development and Global Health is a critical step in helping to protect the most vulnerable children world-wide. Our expertise in clinical trials will help set the stage toward final delivery of an important vaccine that could impact millions,” said Kathleen Neuzil, MD, MPH, the Myron M. Levine Professor in Vaccinology, Professor of Medicine and Pediatrics and Director of the CVD.
Diarrheal diseases can typically be treated through rehydration therapy and with antibiotics for travelers to countries and regions where there is a high prevalence. However, many who are exposed to these pathogens — children under the age of five and others in low resource settings — do not always have access to these treatments. A vaccine, when finally tested and approved, could offer broad protection.
“Diarrheal diseases are one of the biggest challenges in global health. Our researchers at the University of Maryland School of Medicine have developed critical tools to protect children and others in settings where there is high risk. This work not only tackles some of the most challenging diseases, but it will ultimately impact millions of people around the world,” said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs at UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine.
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About the University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world — with 43 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished recipient of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for more than 1.2 million patients each year. The School has over 2,500 students, residents, and fellows, and more than $540 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total workforce of nearly 7,000 individuals. The combined School and Medical System (“University of Maryland Medicine”) has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
About the UMSOM Center for Vaccine Development and Global Health
For over 40 years, researchers in the Center for Vaccine Development and Global Health have worked domestically and internationally to develop, test, and deploy vaccines to aid the world’s underserved populations. CVD is an academic enterprise engaged in the full range of infectious disease intervention from basic laboratory research through vaccine development, pre-clinical and clinical evaluation, large-scale pre-licensure field studies, and post-licensure assessments. CVD has worked to eliminate vaccine-preventable diseases. CVD has created and tested vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, nosocomial pathogens, tularemia, influenza, and other infectious diseases. CVD’s research covers the broader goal of improving global health by conducting innovative, leading research in Baltimore and around the world. CVD researchers are developing new and improved ways to diagnose, prevent, treat, control, and eradicate diseases of global impact. Currently, these diseases include malaria, typhoid, Shigella and other vaccine-preventable infectious diseases. CVD researchers have been involved in critical vaccine development for emerging pathogens such as Zika and Ebola. In addition, CVD’s work focuses on the ever-growing challenge of anti-microbial resistance.
About Emergent BioSolutions Inc
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats. We aspire to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. Additional information about the company may be found at //www.