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Phase I Study of ETEC Vaccine

NCT01147445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-07

No results posted yet for this study

Summary

The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vaccine that can be given without causing severe side effects. Most E. coli bacteria are harmless to humans and can even be beneficial. However, some are harmful, and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples, and documenting side effects. Participants will be involved in study related procedures for about 8 months.

Conditions

  • Gastroenteritis Escherichia Coli

Interventions

BIOLOGICAL

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

LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat labile enterotoxin. LT(R192G/L211A) is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700 micrograms of vaccine protein in a 3 mL, multi-dose, Wheaton Serum Vial. Vaccine dosage levels: 5, 25, 50, 100 micrograms as a single, oral dose.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-13
Primary Completion
2012-06-08
Completion
2012-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147445 on ClinicalTrials.gov