MedTrace Logo

Dose-Finding Study of CS19 Expressing ETEC Challenge Strains

NCT00564863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-04-05

No results posted yet for this study

Summary

This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as the initial step to establish a human disease model. If an 80% attack rate (AR) for predefined diarrheal disease is achieved without high output diarrhea, the same inoculum will be given to 5 - 10 more subjects for confirmation of AR. If an 80% AR is not achieved, AR and severity of disease will be evaluated to determine if the dose should be increased. The same sequence may be conducted with DS26-1 as necessary. If the WS0115A strain causes high output diarrhea, the dose will be adjusted down and further dose characterization continued. An iterative process will be used to select the optimal strain and dose with each step reviewed and approved by the medical monitor.

Conditions

  • Travelers' Diarrhea

Interventions

BIOLOGICAL

CS19 expressing ETEC strain

Wild type ETEC strain expressing the colonization faction CS19, and LT and ST enterotoxins.

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Robin McKenzie, M.D. · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-09-04

Countries

  • United States

Study Locations

More Related Trials

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 NCT00564863 on ClinicalTrials.gov