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Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I

NCT00435526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-02-15

No results posted yet for this study

Summary

The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with H10407, a CFA/I-expressing ETEC strain.

Conditions

Interventions

BIOLOGICAL

anti-CFA/I bovine IgG, and anti-CfaE bovine IgG

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Completion
2006-10-31

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 NCT00435526 on ClinicalTrials.gov