A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Intradermal (ID) Vaccination in Healthy Adults
The Phase 1 clinical trial for the dmLT vaccine, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), aims to establish the safety and immunogenicity of this candidate vaccine in healthy adults. Given the global burden of enterotoxigenic Escherichia coli (ETEC) infections, particularly in developing regions, a successful outcome could position this vaccine as a critical preventive measure in public health. The market potential is significant, especially in endemic areas, and could lead to partnerships with global health organizations and governments. Competitive analysis indicates that while there are existing vaccines for cholera, the specific targeting of ETEC through dmLT could provide a unique market niche. Diligence should focus on the regulatory pathway and potential for expedited approval given the public health implications.
Indication: Gastroenteritis Escherichia Coli
Modality: vaccine
Target: Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Source URL: ClinicalTrials.gov
Source updated: Oct 26, 2020
Ingested: Jun 13, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)
View original source fields
Condition raw: Gastroenteritis Escherichia Coli
Condition normalized: Gastroenteritis Escherichia Coli
Modality raw: vaccine
Modality normalized: vaccine
Target raw: Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)
Target normalized: Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)