Healthy VolunteerPhase 1NCT06122870
CampETEC Hyperimmune Bovine Colostrum (HBC)
A Phase 1 study testing CampETEC HBC product, ProMilk 85 and C. jejuni CG8421 Challenge strain in people with Healthy Volunteer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- CampETEC HBC product, ProMilk 85 and C. jejuni CG8421 Challenge strain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 4 Jun 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 < 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.
Show all 31Show fewer
- 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.
- Use of antibiotics during the 7 days before bacterial dosing or receipt of more than 2 courses of antibiotics over the two months prior to dosing.
- Blood donation within 30 days prior to the planned receipt of this investigational product.
- Lactose intolerance or allergy to milk or milk products.
- Personal or documented family history of Guillain-Barré syndrome or neuromuscular disease; or an inflammatory arthritis such as reactive arthritis, ankylosing spondylitis, or rheumatoid arthritis.
- Evidence of inflammatory arthritis on exam
- human leukocyte antigen B27(HLA B27) positive
- Allergy or prior intolerance to two or more of the following: fluoroquinolone, azithromycin, augmentin or cephalosporins.
- Have household contacts who are <2 years old or > 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University (Center for Immunization Research)
Baltimore, Maryland, 21224
About this study
Official title: Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases
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.
Read the detailed description
Controlled Human Infection ModelCampylobacter is a leading cause of foodborne disease in the US, is associated with 7.5 million disability adjusted life years globally and is a pathogen of concern in pediatric populations in LMICs and adult travelers to those same regions. Campylobacteriosis disproportionately affects poor and marginalized populations of the developing world and is particularly hazardous to the health and viability of infants in this region. The global diarrhea burden caused by Campylobacter spp. is estimated to include 88 million episodes in children aged ≤5 years, resulting in roughly 41,000 deaths. Among all age groups, the estimates of episodes and deaths are roughly 172 million and 75,000, respectively. In the US, Campylobacter causes more than 1.5 million illnesses each year mostly due to the handling and consumption of raw or undercooked poultry. For travelers, Campylobacter causes a severe form of Traveler's Diarrhea (TD), often associated with longer illness duration, increased number of unformed stools, and a high frequency of other symptoms (abdominal pain, nausea, vomiting, and fever) in comparison with other TD etiologies. In addition, Campylobacter infection is associated with several important sequelae, including Guillain-Barré syndrome (GBS), reactive arthritis, irritable bowel syndrome, and, to a lesser extent, inflammatory bowel disease. Until recently, campylobacteriosis has been viewed as a self-limiting illness that is ameliorated by antibiotic treatment; however, resistance of Campylobacter to antibiotics, particularly fluoroquinolones, has become a concern. Thus, alternative measures to control infection are needed. C. jejuni lacks virulence factors analogous to those of better-characterized pathogens. However, the C. jejuni Capsular polysaccharide (CPS) was recently identified and is now recognized as a major virulence factor and the focus of vaccine development efforts. A total of 47 C. jejuni capsule types have been described and through structure homology can be collapsed into 35 groups. Based on scant epidemiological data from developing countries, it appears that a limited number of C. jejuni capsule types are responsible for the majority of the disease.
One modality that has shown considerable promise in diarrhea prevention is passive, oral administration of HBC, hyperimmune bovine colostrum. In a number of clinical trials, HBC as well as bovine serum IgG (BSIgG), with specific activity against enteropathogens like Enterotoxigenic E. coli (ETEC), Shigella, and rotavirus, have shown to prevent diarrheal disease in Controlled Human Infection Models (CHIM). This study will establish the foundation for evaluating HBC products against Campylobacter.
This randomized, double-blinded, placebo- controlled study will explore if Hyperimmune bovine colostrum provides protection against oral challenges with Campylobacter in healthy adult participants. There will be an inpatient admission of approximately 30 subjects. Participants will be randomized to receive the investigational product (IP) or placebo three times daily following meals beginning 2 days prior to challenge. Each volunteer will be challenged with C.jeuni strain CG8421 on Day 1. The investigational product/placebo will be administered for a total of 7 days, or until antibiotic treatment has been administered. The investigators hypothesize that HBC will provide protection against C. jejuni strain CG8421 mediated moderate to severe diarrhea upon challenge.
- Conditions
- Healthy Volunteer
- Being tested
- CampETEC HBC product, ProMilk 85, C. jejuni CG8421 Challenge strain
- Keywords
- Campylobacter, CG8421, Challenge, Hyperimmune Bovine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CampETEC HBC productBiological
Immunoglobulin from bovine milk/colostrum and challenge strain
ProMilk 85Biological
Placebo ProMilk 85
C. jejuni CG8421 Challenge strainBiological
Challenge strain C. jejuni CG8421
| Study group | Role | What they receive |
|---|---|---|
| CampETEC HBC group | Experimental | CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421 Receives: 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 Receives: Biological: ProMilk 85; Biological: C. jejuni CG8421 Challenge strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 144 hours of challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start4 Dec 2023
- Primary completion4 Jun 2024
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, United States Department of Defense, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Kawsar R Talaat, MD, Principal investigator, Johns Hopkins Center for Immunization Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122870
- Sponsor's protocol ID
- CIR 360
- Other IDs
- IRB00026228
- Status last verified
- Aug 2025
- First submitted
- 3 Nov 2023
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA, Roy SL, Jones JL, Griffin PM. Foodborne illness acquired in the United States--major pathogens. Emerg Infect Dis. 2011 Jan;17(1):7-15. doi: 10.3201/eid1701.p11101.
PubMed 21192848Olson S, Hall A, Riddle MS, Porter CK. Travelers' diarrhea: update on the incidence, etiology and risk in military and similar populations - 1990-2005 versus 2005-2015, does a decade make a difference? Trop Dis Travel Med Vaccines. 2019 Jan 15;5:1. doi: 10.1186/s40794-018-0077-1. eCollection 2019.
PubMed 30675367Platts-Mills JA, Babji S, Bodhidatta L, Gratz J, Haque R, Havt A, McCormick BJ, McGrath M, Olortegui MP, Samie A, Shakoor S, Mondal D, Lima IF, Hariraju D, Rayamajhi BB, Qureshi S, Kabir F, Yori PP, Mufamadi B, Amour C, Carreon JD, Richard SA, Lang D, Bessong P, Mduma E, Ahmed T, Lima AA, Mason CJ, Zaidi AK, Bhutta ZA, Kosek M, Guerrant RL, Gottlieb M, Miller M, Kang G, Houpt ER; MAL-ED Network Investigators. Pathogen-specific burdens of community diarrhoea in developing countries: a multisite birth cohort study (MAL-ED). Lancet Glob Health. 2015 Sep;3(9):e564-75. doi: 10.1016/S2214-109X(15)00151-5. Epub 2015 Jul 19.
PubMed 26202075GBD 2016 Diarrhoeal Disease Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Nov;18(11):1211-1228. doi: 10.1016/S1473-3099(18)30362-1. Epub 2018 Sep 19.
PubMed 30243583Patrick ME, Henao OL, Robinson T, Geissler AL, Cronquist A, Hanna S, Hurd S, Medalla F, Pruckler J, Mahon BE. Features of illnesses caused by five species of Campylobacter, Foodborne Diseases Active Surveillance Network (FoodNet) - 2010-2015. Epidemiol Infect. 2018 Jan;146(1):1-10. doi: 10.1017/S0950268817002370. Epub 2017 Dec 14.
PubMed 29237513Connor BA, Riddle MS. Post-infectious sequelae of travelers' diarrhea. J Travel Med. 2013 Sep-Oct;20(5):303-12. doi: 10.1111/jtm.12049. Epub 2013 Jul 9.
PubMed 23992573Schwartz KL, Morris SK. Travel and the Spread of Drug-Resistant Bacteria. Curr Infect Dis Rep. 2018 Jun 29;20(9):29. doi: 10.1007/s11908-018-0634-9.
PubMed 29959541Novik V, Hofreuter D, Galan JE. Characterization of a Campylobacter jejuni VirK protein homolog as a novel virulence determinant. Infect Immun. 2009 Dec;77(12):5428-36. doi: 10.1128/IAI.00528-09. Epub 2009 Sep 21.
PubMed 19797067Parkhill J, Wren BW, Mungall K, Ketley JM, Churcher C, Basham D, Chillingworth T, Davies RM, Feltwell T, Holroyd S, Jagels K, Karlyshev AV, Moule S, Pallen MJ, Penn CW, Quail MA, Rajandream MA, Rutherford KM, van Vliet AH, Whitehead S, Barrell BG. The genome sequence of the food-borne pathogen Campylobacter jejuni reveals hypervariable sequences. Nature. 2000 Feb 10;403(6770):665-8. doi: 10.1038/35001088.
PubMed 10688204Karlyshev AV, Champion OL, Churcher C, Brisson JR, Jarrell HC, Gilbert M, Brochu D, St Michael F, Li J, Wakarchuk WW, Goodhead I, Sanders M, Stevens K, White B, Parkhill J, Wren BW, Szymanski CM. Analysis of Campylobacter jejuni capsular loci reveals multiple mechanisms for the generation of structural diversity and the ability to form complex heptoses. Mol Microbiol. 2005 Jan;55(1):90-103. doi: 10.1111/j.1365-2958.2004.04374.x.
PubMed 15612919Maue AC, Poly F, Guerry P. A capsule conjugate vaccine approach to prevent diarrheal disease caused by Campylobacter jejuni. Hum Vaccin Immunother. 2014;10(6):1499-504. doi: 10.4161/hv.27985. Epub 2014 Mar 14.
PubMed 24632556Pike BL, Guerry P, Poly F. Global Distribution of Campylobacter jejuni Penner Serotypes: A Systematic Review. PLoS One. 2013 Jun 27;8(6):e67375. doi: 10.1371/journal.pone.0067375. Print 2013.
PubMed 23826280Tacket CO, Losonsky G, Link H, Hoang Y, Guesry P, Hilpert H, Levine MM. Protection by milk immunoglobulin concentrate against oral challenge with enterotoxigenic Escherichia coli. N Engl J Med. 1988 May 12;318(19):1240-3. doi: 10.1056/NEJM198805123181904.
PubMed 3283555Tacket CO, Binion SB, Bostwick E, Losonsky G, Roy MJ, Edelman R. Efficacy of bovine milk immunoglobulin concentrate in preventing illness after Shigella flexneri challenge. Am J Trop Med Hyg. 1992 Sep;47(3):276-83. doi: 10.4269/ajtmh.1992.47.276.
PubMed 1524140Davidson GP, Whyte PB, Daniels E, Franklin K, Nunan H, McCloud PI, Moore AG, Moore DJ. Passive immunisation of children with bovine colostrum containing antibodies to human rotavirus. Lancet. 1989 Sep 23;2(8665):709-12. doi: 10.1016/s0140-6736(89)90771-x.
PubMed 2570959
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases
- ClinicalTrials.gov ID
- NCT06122870
- Acronym / sponsor ID
- CIR 360
- Conditions
- Healthy Volunteer
- Keywords
- Campylobacter, CG8421, Challenge, Hyperimmune Bovine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Naval Medical Research Center, United States Department of Defense, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Controlled Human Infection ModelCampylobacter is a leading cause of foodborne disease in the US, is associated with 7.5 million disability adjusted life years globally and is a pathogen of concern in pediatric populations in LMICs and adult travelers to those same regions. Campylobacteriosis disproportionately affects poor and marginalized populations of the developing world and is particularly hazardous to the health and viability of infants in this region. The global diarrhea burden caused by Campylobacter spp. is estimated to include 88 million episodes in children aged ≤5 years, resulting in roughly 41,000 deaths. Among all age groups, the estimates of episodes and deaths are roughly 172 million and 75,000, respectively. In the US, Campylobacter causes more than 1.5 million illnesses each year mostly due to the handling and consumption of raw or undercooked poultry. For travelers, Campylobacter causes a severe form of Traveler's Diarrhea (TD), often associated with longer illness duration, increased number of unformed stools, and a high frequency of other symptoms (abdominal pain, nausea, vomiting, and fever) in comparison with other TD etiologies. In addition, Campylobacter infection is associated with several important sequelae, including Guillain-Barré syndrome (GBS), reactive arthritis, irritable bowel syndrome, and, to a lesser extent, inflammatory bowel disease. Until recently, campylobacteriosis has been viewed as a self-limiting illness that is ameliorated by antibiotic treatment; however, resistance of Campylobacter to antibiotics, particularly fluoroquinolones, has become a concern. Thus, alternative measures to control infection are needed. C. jejuni lacks virulence factors analogous to those of better-characterized pathogens. However, the C. jejuni Capsular polysaccharide (CPS) was recently identified and is now recognized as a major virulence factor and the focus of vaccine development efforts. A total of 47 C. jejuni capsule types have been described and through structure homology can be collapsed into 35 groups. Based on scant epidemiological data from developing countries, it appears that a limited number of C. jejuni capsule types are responsible for the majority of the disease.
One modality that has shown considerable promise in diarrhea prevention is passive, oral administration of HBC, hyperimmune bovine colostrum. In a number of clinical trials, HBC as well as bovine serum IgG (BSIgG), with specific activity against enteropathogens like Enterotoxigenic E. coli (ETEC), Shigella, and rotavirus, have shown to prevent diarrheal disease in Controlled Human Infection Models (CHIM). This study will establish the foundation for evaluating HBC products against Campylobacter.
This randomized, double-blinded, placebo- controlled study will explore if Hyperimmune bovine colostrum provides protection against oral challenges with Campylobacter in healthy adult participants. There will be an inpatient admission of approximately 30 subjects. Participants will be randomized to receive the investigational product (IP) or placebo three times daily following meals beginning 2 days prior to challenge. Each volunteer will be challenged with C.jeuni strain CG8421 on Day 1. The investigational product/placebo will be administered for a total of 7 days, or until antibiotic treatment has been administered. The investigators hypothesize that HBC will provide protection against C. jejuni strain CG8421 mediated moderate to severe diarrhea upon challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CampETEC HBC group | Experimental | Biological: CampETEC HBC product, Biological: C. jejuni CG8421 Challenge strainCampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421 |
| Placebo ProMilk 85 group | Placebo comparator | Biological: ProMilk 85, Biological: C. jejuni CG8421 Challenge strainProMilk 85 (placebo) and challenge strain C.jejuni CG8421 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (31 listed)
- 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 < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CampETEC HBC productImmunoglobulin from bovine milk/colostrum and challenge strain | Biological | CampETEC HBC group |
| ProMilk 85Placebo ProMilk 85 | Biological | Placebo ProMilk 85 group |
| C. jejuni CG8421 Challenge strainChallenge strain C. jejuni CG8421 | Biological | CampETEC HBC group, Placebo ProMilk 85 group |
Primary outcome
Incidence of Adverse Events
Time frame: 28 days
The primary safety and tolerability outcome is the presence of CampETEC HBC associated adverse events during the study period. Safety of CampETEC HBC.
Number of Participants With Campylobacteriosis Patterns
Time frame: Within 144 hours of challenge
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21192848Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA, Roy SL, Jones JL, Griffin PM. Foodborne illness acquired in the United States--major pathogens. Emerg Infect Dis. 2011 Jan;17(1):7-15. doi: 10.3201/eid1701.p11101.
- Background: PubMed 30675367Olson S, Hall A, Riddle MS, Porter CK. Travelers' diarrhea: update on the incidence, etiology and risk in military and similar populations - 1990-2005 versus 2005-2015, does a decade make a difference? Trop Dis Travel Med Vaccines. 2019 Jan 15;5:1. doi: 10.1186/s40794-018-0077-1. eCollection 2019.
- Background: PubMed 26202075Platts-Mills JA, Babji S, Bodhidatta L, Gratz J, Haque R, Havt A, McCormick BJ, McGrath M, Olortegui MP, Samie A, Shakoor S, Mondal D, Lima IF, Hariraju D, Rayamajhi BB, Qureshi S, Kabir F, Yori PP, Mufamadi B, Amour C, Carreon JD, Richard SA, Lang D, Bessong P, Mduma E, Ahmed T, Lima AA, Mason CJ, Zaidi AK, Bhutta ZA, Kosek M, Guerrant RL, Gottlieb M, Miller M, Kang G, Houpt ER; MAL-ED Network Investigators. Pathogen-specific burdens of community diarrhoea in developing countries: a multisite birth cohort study (MAL-ED). Lancet Glob Health. 2015 Sep;3(9):e564-75. doi: 10.1016/S2214-109X(15)00151-5. Epub 2015 Jul 19.
- Background: PubMed 30243583GBD 2016 Diarrhoeal Disease Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Nov;18(11):1211-1228. doi: 10.1016/S1473-3099(18)30362-1. Epub 2018 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kawsar R Talaat, MD principal investigator
Johns Hopkins Center for Immunization Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CampETEC HBC product, ProMilk 85 and C. jejuni CG8421 Challenge strain in people with Healthy Volunteer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122870, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.