Protective Efficacy of Orally Delivered Bovine Serum Immunoglobulin (BSIgG) Specific for the Colonization Factor CS6 Following Challenge With the CS6-expressing Enterotoxigenic E. Coli (ETEC) Strain B7A

NCT03040687 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2017-01
Completion	2017-08

Conditions

• Healthy Volunteer

Interventions

• Anti CS6 BSIgG product (Lot PD1601105CS)
• Anti B7A BSIgG product (Lot PD1601132ET)
• Bovine Immunoglobin Negative Control (Lot PD161071NC)
• B7A- CS6-expressing ETEC challenge strain

Primary outcomes

• Safety of Serum Derived Bovine Immunoglobulins (BSIgG) — 28 days
  Number of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.
• Efficacy of B7A and CS6- Hyperimmune Bovine Serum Immunoglobin to Protect Against Moderate to Severe Diarrhea After Challenge With the CS6 Expressing ETEC Strain B7A — 28 days
  Comparison of the number and percentage of volunteers in the arms receiving the B7A- and CS6 BSIgG vs the arm receiving the nonhyperimmune BSIgG who develop moderate to severe diarrhea.

Countries

United States