CampETEC Hyperimmune Bovine Colostrum (HBC)

NCT06122870 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CIR 360IRB00026228
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal infections cause significant morbidity in the form of acute diarrheal illness in the United States (US) and among travelers to low- and middle-income countries (LMICs). One approach is to use passive protection (antibodies) to prevent infection. The purpose of this study are to assess the safety and tolerability 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 Campylobacter C. jejuni strain CG8421.

Conditions

Healthy Volunteer

Keywords

Campylobacter; CG8421; Challenge; Hyperimmune Bovine

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  The primary safety and tolerability outcome is the presence of CampETEC HBC associated adverse events during the study period. Safety of CampETEC HBC.

  28 days

• Number of Participants With Campylobacteriosis Patterns

  The primary efficacy outcome is campylobacteriosis, defined as a clinical illness meeting at least one of the following patterns starting within 144 hours of challenge * Moderate diarrhea (4 to 5 loose/liquid stools or 401-800 grams in any 24 hour period) OR * Severe diarrhea (≥ 6 loose/liquid stools or \> 800 grams in any 24 hour period) OR * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or dysentery (gross blood in ≥ 2 grade 3 - 5 stools with in any 24 hour period); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.

  Within 144 hours of challenge

Study Arms (2)

CampETEC HBC group

EXPERIMENTAL

CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421

Biological: CampETEC HBC product; Biological: C. jejuni CG8421 Challenge strain

Placebo ProMilk 85 group

PLACEBO COMPARATOR

ProMilk 85 (placebo) and challenge strain C.jejuni CG8421

Biological: ProMilk 85; Biological: C. jejuni CG8421 Challenge strain

Interventions

CampETEC HBC product BIOLOGICAL

Immunoglobulin from bovine milk/colostrum and challenge strain

CampETEC HBC group

ProMilk 85 BIOLOGICAL

Placebo ProMilk 85

Placebo ProMilk 85 group

C. jejuni CG8421 Challenge strain BIOLOGICAL

Challenge strain C. jejuni CG8421

CampETEC HBC group; Placebo ProMilk 85 group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• General health issues
• Immunosuppressive illness or evidence of immunoglobulin A( IgA) deficiency (serum IgA \< 7 mg/dL or below the limit of detection of assay). This includes any disease that requires immunosuppressive medication such corticosteroids, monoclonal antibodies that target key aspects of the immune system (e.g. rituximab or tumor necrosis factor (TNF) blockers, or any autoimmune disease).
• Positive serology results for HIV, HBsAg, or hepatitis C virus (HCV) antibodies, and confirmatory tests if appropriate.
• Positive urine toxicology screen for Amphetamines, Barbiturates, Benzodiazepines, cocaine metabolite, Methadone metabolite, Opiates, Oxycodone, and/or Phencyclidine.
• Significant abnormalities in screening laboratory hematology or serum chemistry, as determined by PI or PI in consultation with the research monitor and sponsor.
• Use of any medication known to affect immune function (e.g., regular systemic corticosteroids, monoclonal antibodies that target key aspects of the immune system (such as rituximab or tumor necrosis factor blockers); others \[topical, intranasal and inhaled steroids will be permitted\]) within 30 days preceding receipt of the investigational product or planned to be used during the active study period.
• Nursing or lactating on the day of admittance to the inpatient unit.
• Inability to tolerate 150 mL sodium bicarbonate buffer (based on requirement for frequent dosing).
• Recent vaccination (including licensed vaccines) or receipt of an investigational product (within 30 days before challenge through 30 days following the challenge dose).
• Prior history of C. difficile infection
• History of diarrhea in the 2 weeks prior to planned inpatient phase.
• Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, or loose or liquid stools other than on an occasional basis.
• Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly).
• Use of proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
• A fever (≥ 38.0°C) in the 2 weeks prior to time of challenge.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Naval Medical Research Center: collaborator
• United States Department of Defense: collaborator
• The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc: collaborator

Study Sites (1)

Johns Hopkins University (Center for Immunization Research)

Baltimore, Maryland, 21224, United States

Location

Related Publications (19)

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  PMID: 23245608 BACKGROUND

Results Point of Contact

• Title: Dr. Kawsar Talaat
• Organization: Johns Hopkins University

ktalaat@jhu.edu

410-336-9164

Study Officials

• Kawsar R Talaat, MD

  Johns Hopkins Center for Immunization Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: December 4, 2023
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2025
• Last Updated: August 22, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-08

Locations

US (1)