Campylobacter InfectionsPhase 1NCT01048112
Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection
A Phase 1 study testing Campylobacter jejuni strain CG8421 in people with Campylobacter Infections, run by University of Vermont at 2 sites in United States.
Trial summary
The goal of this research is to continue to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection to reinfection with C. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Infections
- What is being tested?
- Campylobacter jejuni strain CG8421
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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 or principal investigator in consultation with the medical monitor and sponsor.
- Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
- Willing to participate after informed consent obtained.
- Available for all planned follow-up visits, and remain available for medical interview/physical exam and monitoring for 90 days post-challenge (last challenge received), and a final telephone interview 180 days post-challenge.
- Negative urine pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for all female subjects. In addition, female subjects will be advised of the need for an effective means of birth control during the entire study period.
Who cannot join
- Presence of a significant medical condition (e.g., psychiatric conditions; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis, inflammatory bowel disease, irritable bowel syndrome; alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
- Immunosuppressive illness, IgA deficiency (below the normal limits), or H2 antihistamine use within 48 h of admission or during inpatient period.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Significant abnormalities in screening lab hematology, serum chemistry, as determined by PI or PI in consultation with the medical monitor and sponsor.
- Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
- Nursing mother on the day of admittance to the inpatient phase for all female subjects.
Show all 19Show fewer
- Are not capable of fully informed consent (e.g., cannot read or write English)
- Personal or documented family history of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or Guillain-Barré syndrome (would not include osteoarthritis or vague history of arthritis in a relative late in adulthood).
- Evidence of neurologic abnormalities (specifically extremity weakness, abnormal deep tendon reflexes, symmetric sensory abnormalities - vibratory, light touch, and proprioception).
- Evidence of inflammatory arthritis on exam and/or HLA-B27 positive (flow cytometry).
- Allergy or prior intolerance to any of the following antibiotics: azithromycin, fluoroquinolones, or penicillin.
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, 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).
- Have household contacts who are <2 years old or >80 years old or infirmed or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
- Employment as either a health care worker with direct patient care, in a daycare center (for children or the elderly), or working directly with food.
- History of microbiologically confirmed Campylobacter infection
- Immunologic evidence of Campylobacter exposure
- Individuals who have traveled to countries with high Campylobacter rates within the past two years and who experienced an episode of diarrhea during or within 1 week of returning from their trip.
- And others
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05401
Beth Kirkpatrick, MD
Ann Fingar, MD
- Not yet recruiting
Navy Medical Research Center
Silver Spring, Maryland, 20910
David Tribble, MD
Douglas Hawk, MD
About this study
The goal of this research is to continue to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection to reinfection with C. jejuni; and 2) characterize the immune responses to C. jejuni infection. Information obtained will be used in development of a vaccine against Campylobacter infections.
Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening will include obtaining informed consent prior to any study procedure. This will be followed by medical history, physical examination, review of current medications, blood samples for safety labs (WBC, Hct, Hgb, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV, and HCV); urine pregnancy testing for females. Stool will be tested for infection.
Read more
Eligible volunteers will be enrolled in the study and admitted to the GCRC on Day -1. They will drink a measured dose of C. jejuni on Day 0, and followed for approximately 9 inpatient days, during which time the investigators expect at least 75% to develop a diarrheal illness, which will be promptly treated with replacement fluids (oral or IV, as indicated) and antibiotics. During the inpatient period, subjects will be assessed for any adverse events, and blood and stool specimens will be analyzed for markers of infection and markers of immune response. Subjects must have resolved or resolving symptoms and two negative stool cultures ≥12 hours apart to be eligible for discharge, and will be seen in outpatient follow-up at 21, 28, 35, 60, and 90 days for additional AE assessments and blood and stool analysis.
Eight subjects will return for redosing approximately 98 days after the initial dose, with the same inpatient and outpatient follow-up as above. Few or none should develop a diarrheal illness. Four naïve (previously unexposed) subjects will also receive the dose on Day 98 to confirm a 75% illness rate with this dose. They will be followed as the initial group was. All participants will be assessed by phone 6 months after the final dose they received.
- Conditions
- Campylobacter Infections
- Being tested
- Campylobacter jejuni strain CG8421
- Keywords
- campylobacter, gastroenteritis, challenge models
- Medical subject headings
- Campylobacter Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campylobacter jejuni strain CG8421Biological
Single oral dose of Campylobacter jejuni strain CG8421 in sodium bicarbonate buffer
| Study group | Role | What they receive |
|---|---|---|
| Repeated dose group | Experimental | Will receive one dose of Campylobacter jejuni strain CG8421 at day 0 and a second dose at approximately day 98. Receives: Biological: Campylobacter jejuni strain CG8421 |
| Single dose group | Active comparator | Will receive one dose of Campylobacter jejuni strain CG8421 Receives: Biological: Campylobacter jejuni strain CG8421 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of campylobacteriosis in response to a dose of Campylobacter jejuni strain CG8421
Measured: 10 days
Immunologic responses to dosing with Campylobacter jejuni strain CG8421
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Campylobacter InfectionsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Medical Materiel Development Activity, Naval Medical Research Center
- Investigators
- Beth Kirkpatrick, MD, Principal investigator, University of VermontDavid Tribble, MD, Principal investigator, Navy Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048112
- Sponsor's protocol ID
- CHRMS 10-086
- Other IDs
- NMRC 2009.0017
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirkpatrick BD, Lyon CE, Porter CK, Maue AC, Guerry P, Pierce KK, Carmolli MP, Riddle MS, Larsson CJ, Hawk D, Dill EA, Fingar A, Poly F, Fimlaid KA, Hoq F, Tribble DR. Lack of homologous protection against Campylobacter jejuni CG8421 in a human challenge model. Clin Infect Dis. 2013 Oct;57(8):1106-13. doi: 10.1093/cid/cit454. Epub 2013 Jul 9.
PubMed 23840001
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection
- ClinicalTrials.gov ID
- NCT01048112
- Acronym / sponsor ID
- CHRMS 10-086
- Conditions
- Campylobacter Infections
- Keywords
- campylobacter, gastroenteritis, challenge models
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- United States Army Medical Materiel Development Activity, Naval Medical Research Center
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to continue to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection to reinfection with C. jejuni; and 2) characterize the immune responses to C. jejuni infection. Information obtained will be used in development of a vaccine against Campylobacter infections.
Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening will include obtaining informed consent prior to any study procedure. This will be followed by medical history, physical examination, review of current medications, blood samples for safety labs (WBC, Hct, Hgb, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV, and HCV); urine pregnancy testing for females. Stool will be tested for infection.
Eligible volunteers will be enrolled in the study and admitted to the GCRC on Day -1. They will drink a measured dose of C. jejuni on Day 0, and followed for approximately 9 inpatient days, during which time the investigators expect at least 75% to develop a diarrheal illness, which will be promptly treated with replacement fluids (oral or IV, as indicated) and antibiotics. During the inpatient period, subjects will be assessed for any adverse events, and blood and stool specimens will be analyzed for markers of infection and markers of immune response. Subjects must have resolved or resolving symptoms and two negative stool cultures ≥12 hours apart to be eligible for discharge, and will be seen in outpatient follow-up at 21, 28, 35, 60, and 90 days for additional AE assessments and blood and stool analysis.
Eight subjects will return for redosing approximately 98 days after the initial dose, with the same inpatient and outpatient follow-up as above. Few or none should develop a diarrheal illness. Four naïve (previously unexposed) subjects will also receive the dose on Day 98 to confirm a 75% illness rate with this dose. They will be followed as the initial group was. All participants will be assessed by phone 6 months after the final dose they received.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated dose group | Experimental | Biological: Campylobacter jejuni strain CG8421Will receive one dose of Campylobacter jejuni strain CG8421 at day 0 and a second dose at approximately day 98. |
| Single dose group | Active comparator | Biological: Campylobacter jejuni strain CG8421Will receive one dose of Campylobacter jejuni strain CG8421 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 or principal investigator in consultation with the medical monitor and sponsor.
- Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
- Willing to participate after informed consent obtained.
- Available for all planned follow-up visits, and remain available for medical interview/physical exam and monitoring for 90 days post-challenge (last challenge received), and a final telephone interview 180 days post-challenge.
Key exclusion criteria (19 listed)
- Presence of a significant medical condition (e.g., psychiatric conditions; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis, inflammatory bowel disease, irritable bowel syndrome; alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
- Immunosuppressive illness, IgA deficiency (below the normal limits), or H2 antihistamine use within 48 h of admission or during inpatient period.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Significant abnormalities in screening lab hematology, serum chemistry, as determined by PI or PI in consultation with the medical monitor and sponsor.
- Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
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 |
|---|---|---|
| Campylobacter jejuni strain CG8421Single oral dose of Campylobacter jejuni strain CG8421 in sodium bicarbonate buffer | Biological | Repeated dose group, Single dose group |
Primary outcome
Development of campylobacteriosis in response to a dose of Campylobacter jejuni strain CG8421
Time frame: 10 days
Immunologic responses to dosing with Campylobacter jejuni strain CG8421
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Derived from this study: PubMed 23840001Kirkpatrick BD, Lyon CE, Porter CK, Maue AC, Guerry P, Pierce KK, Carmolli MP, Riddle MS, Larsson CJ, Hawk D, Dill EA, Fingar A, Poly F, Fimlaid KA, Hoq F, Tribble DR. Lack of homologous protection against Campylobacter jejuni CG8421 in a human challenge model. Clin Infect Dis. 2013 Oct;57(8):1106-13. doi: 10.1093/cid/cit454. Epub 2013 Jul 9.
- UVM Vaccine Testing CenterLink provided by the sponsor.
Related trials for Campylobacter Infections
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
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.
Beth Kirkpatrick, MD principal investigator
University of Vermont
David Tribble, MD principal investigator
Navy Medical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Campylobacter jejuni strain CG8421 in people with Campylobacter Infections, run by University of Vermont at 2 sites 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 19 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: status not confirmed, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Larsson (802-656-9298, cathy.larsson@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of campylobacteriosis in response to a dose of Campylobacter jejuni strain CG8421 (time frame: 10 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 NCT01048112, which also lists 1 linked publication.
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 13 Jan 2010.