IDCRC launches clinical trial to evaluate vaccine aimed at preventing illness caused by ETEC
Infectious Diseases Clinical Research Consortium (IDCRC) researchers have recently launched a randomized, double-blind, placebo-controlled study to evaluate a vaccine aimed at preventing moderate-severe diarrhea caused by Enterotoxigenic Escherichia coli (ETEC).
This Phase 2b trial is designed to evaluate the safety, immunogenicity, and efficacy of the intramuscular administration of a CS6 based vaccine (CssBA) against ETEC co-administered with double mutant labile toxin (dmLT) in preventing moderate-severe diarrhea following challenge with ETEC strain B7A in healthy non-pregnant and non-lactating adults. There is currently no licensed vaccine for ETEC in humans.
“Globally, diarrheal diseases are the second leading cause of death in children. A major cause of diarrhea among children in resource-poor areas is enterotoxigenic E. coli (ETEC) resulting in 210 million diarrhea episodes and approximately 380,000 deaths worldwide every year. Thus, effective vaccines against diarrhea would significantly improve the health of children as well as travelers to areas where ETEC is common," shares Protocol Chair, Robert W. Frenck, Jr., MD, professor and director, Gamble Vaccine Research Center, Cincinnati Children’s Hospital and Medical Center.
ETEC infections occur when contaminated food or water is ingested. Improving access to clean water and enhancing hygiene practices could significantly reduce the incidence of illnesses caused by ETEC. While efforts to achieve these long-term goals are underway, there is an urgent need for additional protective measures, such as vaccines.
“This will be an important assessment of whether a parenterally administered vaccine which targets the fimbrial antigen of ETEC can provide protection. Our two clinical sites are uniquely positioned to evaluate the efficacy of this ETEC vaccine using challenge models because of the long-standing research collaborations on enteric vaccine projects between our two sites," says Protocol Co-Chair, Wilbur H. Chen, MD, Frank M. Calia, MD Endowed Professor, University of Maryland.
The trial is currently enrolling at two IDCRC sites and plans to enroll up to 72 healthy volunteers, who will be followed for approximately 7 months. For additional details, visit ClinicalTrials.gov and search for the identifier NCT06692907.
COU Co-Director, Robert L. Atmar, MD, shares that “There are a lot of moving parts for this study. I want to give a lot of credit to the whole study team for bringing this together.”
Participating IDCRC sites:
- Cincinnati Children's Hospital Medical Center
- University of Maryland School of Medicine
The IDCRC is conducting the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.