MedTrace Logo

Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge

NCT03040687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-06-14

Study results available
· View outcomes & findings →

Summary

Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers. One approach is to use passive protection (antibodies) to prevent infection. The purpose of this study are to assess the safety of serum-derived bovine immunoglobulins in healthy adult subjects when orally administered and to estimate protective efficacy of those preparations against moderate-severe diarrhea upon challenge with the ETEC strain B7A.

Conditions

  • Healthy Volunteer

Interventions

BIOLOGICAL

Anti CS6 BSIgG product (Lot PD1601105CS)

BIOLOGICAL

Anti B7A BSIgG product (Lot PD1601132ET)

BIOLOGICAL

Bovine Immunoglobin Negative Control (Lot PD161071NC)

BIOLOGICAL

B7A- CS6-expressing ETEC challenge strain

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Kawsar R Talaat, MD · Johns Hopkins Center for Immunization Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-04-30
Completion
2017-08-31

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 NCT03040687 on ClinicalTrials.gov