Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Condition: Healthy Volunteer
Intervention: Anti CS6 BSIgG product (Lot PD1601105CS); Anti B7A BSIgG product (Lot PD1601132ET); Bovine Immunoglobin Negative Control (Lot PD161071NC); B7A- CS6-expressing ETEC challenge strain
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ETEC; Escherichia coli; enteritis; challenge; CS6; B7A

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 50 years of age, inclusive.

          -  General good health, without significant medical illness, abnormal physical
             examination findings or clinical laboratory abnormalities as determined by principal
             investigator (PI) or PI in consultation with the research monitor and sponsor.

          -  Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by
             passing a written examination (pass grade ≥ 70%)

          -  Willing to participate after informed consent obtained.

          -  Available for all planned follow-up visits.

          -  Negative serum pregnancy test at screening and negative serum and/or urine pregnancy
             test on the day of admittance to the inpatient phase for female subjects of
             childbearing potential. Females of childbearing potential must agree to use an
             efficacious hormonal or barrier method of birth control during the study. Abstinence
             is acceptable. Female subjects unable to bear children must have this documented
             (e.g., tubal ligation or hysterectomy).

        Exclusion Criteria:

        General health criteria

          -  Presence of a significant medical condition, (e.g. psychiatric conditions or
             gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active
             gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or
             illicit drug abuse/dependency, or other laboratory abnormalities which in the opinion
             of the investigator precludes participation in the study.

          -  Immunosuppressive illness or Immunoglobulin A (IgA) deficiency (serum IgA < 7 mg/dL or
             below the limit of detection of assay)

          -  Evidence of confirmed infection with HIV, HBsAg, or Hepatitis C Virus (HCV), with
             confirmatory assays.

          -  Use of any investigational product within 30 days preceding the receipt of the
             investigational products, or planned use during the active study period

          -  Significant abnormalities in screening lab hematology or serum chemistries, as
             determined by PI or PI in consultation with the research monitor and sponsor.

          -  Lactation or breastfeeding.

        Research-related exclusions applicable to challenge

          -  History of microbiologically confirmed ETEC or cholera infection in last 3 years.

          -  Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3
             years.

          -  Travel to countries where ETEC or cholera infection is endemic (most of the developing
             world) within 3 years prior to dosing.

          -  Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where
             ETEC infection is endemic (most of the developing world) within 3 years prior to
             dosing, OR planned travel to endemic countries during the length of the study.

          -  Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3
             years prior to dosing.

          -  Any prior experimental infection with ETEC strain B7A.

        Study-specific Exclusion Criteria (potential increased risk or complicating outcome
        ascertainment)

          -  Abnormal stool pattern (fewer than 3 per week or more than 3 per day).

          -  History of diarrhea in the 2 weeks prior to planned inpatient phase.

          -  Regular use of laxatives, antacids, or other agents to lower stomach acidity (regular
             defined as at least weekly).

          -  Use of antibiotics during the 7 days before receipt of any investigational