CampETEC Hyperimmune Bovine Colostrum (HBC)

Inclusion Criteria

• Adult 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, requirements, and CHIM by passing a written examination (passing grade ≥ 70%).
• Willing to participate, as evidenced by signing the informed consent document.
• 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 participants of childbearing potential. Participants of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence from intercourse with a male partner is acceptable. Participants who no longer have childbearing potential must have this documented (e.g., tubal ligation or hysterectomy).

Exclusion Criteria

General health issues

• Presence of a significant medical condition (e.g., psychiatric conditions such as significant anxiety, depression, or somatization disorder; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis/dyspepsia, gastroesophageal reflux disease, inflammatory bowel disease, irritable bowel syndrome (as suggested by the functional bowel disorder survey or medical diagnosis); alcohol or illicit drug abuse/dependency; or laboratory abnormalities that in the opinion of the investigator preclude participation in the study. Significant medical conditions include HIV, active Hepatitis B or C infection, ongoing immunosuppression for any reason, autoimmune disease, evidence of cardiac, pulmonary, endocrine, or renal disease that is uncontrolled or poorly controlled, any gastrointestinal illness (chronic reflux, inflammatory bowel disease, ulcer), any diabetes mellitus, and other such illnesses that can put a volunteer at increased risk. Exclusionary laboratory abnormalities include any abnormality that is grade 2 or above.
• Immunosuppressive illness or evidence of immunoglobulin A( IgA) deficiency (serum IgA 80 years old or infirm or immunocompromised.
• Employment as a healthcare worker with direct patient care, in a daycare center (for children or the elderly), or direct food handler; includes individuals who work directly with food in commercial establishments.
• History of microbiologically confirmed Campylobacter infection in the last 3 years.
• Serological immunological evidence of prior Campylobacter exposure as Campylobacter antigen-specific (GE) specific anti glycine extract serum IgA endpoint tier > 1:4,000.
• Occupation involving handling of Campylobacter currently, or in the past 3 years.
• Symptoms consistent with travelers' diarrhea concurrent with travel to countries where Campylobacter, Salmonella, Shigella, Typhoid or ETEC infection are 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 Campylobacter, Cholera, Salmonella, Shigella, Typhoid or ETEC, within 5 years prior to dosing.
• Other dietary or environmental exposures that may place the participant at high risk for prior Campylobacter exposure (to be determined on a case by case basis by the PI).