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Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)

NCT03404674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-06

Study results available
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Summary

This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.

Conditions

Interventions

BIOLOGICAL

CssBA

Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B

BIOLOGICAL

dmLT

Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • PATH

    lead OTHER

Principal Investigators

  • Tida K Lee, MD, PhD · Naval Medical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2019-03-26
Completion
2019-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03404674 on ClinicalTrials.gov