# A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area

> **NCT03548064** · PHASE1 · TERMINATED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 75 (actual)

## Conditions studied

- Gastroenteritis Escherichia Coli
- Immunisation

## Interventions

- **OTHER:** Placebo
- **OTHER:** Placebo
- **OTHER:** Placebo
- **BIOLOGICAL:** Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- **BIOLOGICAL:** Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- **BIOLOGICAL:** Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

## Key facts

- **NCT ID:** NCT03548064
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-03-10
- **Primary completion:** 2020-12-31
- **Final completion:** 2020-12-31
- **Target enrollment:** 75 (ACTUAL)
- **Why stopped:** COVID 19 cases at the site
- **Last updated:** 2025-05-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03548064

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03548064, "A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area". Retrieved via AI Analytics 2026-06-30 from https://api.ai-analytics.org/clinical/NCT03548064. Licensed CC0.

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