NCT00090688

Brief Summary

The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up. Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned. Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2004

Completed
Last Updated

December 28, 2016

Status Verified

January 1, 2006

First QC Date

September 2, 2004

Last Update Submit

December 27, 2016

Conditions

Diarrhea

Keywords

diarrhea

Outcome Measures

Primary Outcomes (3)

  • Safety

  • Mucosal Immunogenicity

  • Systemic Immunogenicity

Interventions

meCS6 + LT(R192G)BIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Available for required follow-up period
  • Women must have a negative pregnancy test
  • Women must not to try to become pregnant while on study and for 2 months after study is completed

You may not qualify if:

  • History of travellers' diarrhea
  • Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine
  • Regular use of anti-diarrheal, anti-constipation, or antacid therapy
  • Abnormal bowel habits
  • Pregnant or nursing women
  • History of chronic gastrointestinal illness or major gastrointestinal surgery
  • Allergies to vaccines
  • Positive HIV, Hepatitis B or Hepatitis C tests
  • Regular use of oral steroid medication
  • Clinically significant abnormalities on physical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20895, United States

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joyce Lapa, MD

    Naval Medical Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 2, 2004

First Posted

September 3, 2004

Study Start

August 1, 2004

Last Updated

December 28, 2016

Record last verified: 2006-01

Locations

US(1)