Publications by authors named "B DeNearing"
Validation of a Human Challenge Model Using an LT-Expressing Enterotoxigenic Strain (LSN03-016011) and Characterization of Potential Amelioration of Disease by an Investigational Oral Vaccine Candidate (VLA1701).
Microorganisms
April 2024
Controlled human infection models are important tools for the evaluation of vaccines against diseases where an appropriate correlate of protection has not been identified. Enterotoxigenic (ETEC) strain LSN03-016011/A (LSN03) is an LT enterotoxin and CS17-expressing ETEC strain useful for evaluating vaccine candidates targeting LT-expressing strains. We sought to confirm the ability of the LSN03 strain to induce moderate-to-severe diarrhea in a healthy American adult population, as well as the impact of immunization with an investigational cholera/ETEC vaccine (VLA-1701) on disease outcomes.
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- ETEC is a major cause of diarrhea, especially affecting travelers, military personnel, and children in low-income countries, and the study focuses on a candidate vaccine targeting one of its virulence factors.
- In the study, 52 healthy adults received three doses of a vaccine (CfaE + LTR192G) intradermally, then were exposed to an ETEC strain to assess the vaccine's effectiveness against diarrhea.
- Results showed the vaccine reduced rates of moderate-to-severe diarrhea by about 27.8%, indicating its potential for protection, but variations in infection rates among the cohorts suggest further investigation is needed.
Article Synopsis
- Shigellosis, a significant cause of diarrhea in young children, is targeted by the Flexyn2a vaccine, which links a part of the bacteria to a harmless toxin to boost immune response.* -
- In a Phase 2b trial involving healthy adults, the Flexyn2a vaccine was found to be safe and resulted in a 30.2% reduction in shigellosis cases, with even higher efficacy against severe cases.* -
- Vaccinated individuals experienced less severe symptoms and needed fewer antibiotics, indicating the vaccine's potential effectiveness in reducing disease severity and improving immune responses.*
Background: Diarrheal diseases are a leading cause of global morbidity and mortality affecting all ages, but especially children under the age of five in resource-limited settings. Shigella is a leading contributor to diarrheal diseases caused by bacterial pathogens and is considered a significant antimicrobial resistance threat. While improvements in hygiene, and access to clean water help as control measures, vaccination remains one of the most viable options for significantly reducing morbidity and mortality.
View Article and Find Full Text PDFBackground: . Oral administration of bovine antibodies active against enterotoxigenic (ETEC) have demonstrated safety and efficacy against diarrhea in human challenge trials. The efficacy of bovine serum immunoglobulins (BSIgG) against recombinant colonization factor CS6 or whole cell ETEC strain B7A was assessed against challenge with the CS6-expressing B7A.
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