Campylobacter InfectionsPhase 1NCT00434798
Campylobacter Jejuni Challenge Model Development: Dose Ranging Study
A Phase 1 study testing Campylobacter jejuni strains CG8421 and BH-01-0142 in people with Campylobacter Infections, run by University of Vermont at 1 site in United States.
Trial summary
The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics: 1. Safe application 1. Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria 2. 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 strains CG8421 and BH-01-0142
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2008
- 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.
- 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.
Who cannot join
- Presence of a significant medical condition, (e.g. psychiatric conditions or 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 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.
- Are not capable of fully informed consent (e.g. cannot read or write English)
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- 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 relatively 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.
- Allergy or prior intolerance to either azithromycin or fluoroquinolones.
- 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 increase gastric pH (regular defined as at least weekly).
- A recent fever in the 2 weeks prior to time of challenge.
- Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
- Use of any investigational product within 30 days preceding the receipt of the challenge inoculum, or planned use during the active study period.
- History of diarrhea in the 2 weeks prior to planned inpatient phase
- Stool culture (collected no more than 1 week prior to admission) positive for Campylobacter, other bacterial enteric pathogens (Salmonella, Shigella, or enterohemorrhagic E. coli), or intestinal parasites.
- 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).
- Work as either a health care personnel with direct patient care, daycare center (for children or the elderly) personnel, or food handlers. Food handlers include individuals who work in restaurants, cafeterias, and retail stores/supermarkets that feature produce, salad bars, and/or deli sections.
- History of microbiologically confirmed Campylobacter infection
- Immunologic evidence of Campylobacter exposure:
- serologic evidence of prior Campylobacter infection [defined as homologous strain Campylobacter-specific anti-glycine extract (GE) IgA OD650 > 0.5 at > 1:1,000 dilution]
- cell mediated immune response evidence of prior Campylobacter infection [in vitro stimulation of PBMC with WC antigen (formalin-fixed homologous strain Campylobacter whole cells) with supernatant IFN-Gamma ≥ 500pg/ml]
- Travel to countries with high Campylobacter rates (to include Asia, Africa, and Central and South America) within two years prior to dosing.
- History of vaccination for or ingestion of Campylobacter.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:
- Safe application
- Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
- Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
- Campylobacteriosis attack rate of at least 75%
Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in the newly established human C. jejuni infection model and evaluate short-term (< 3 mo) protection upon repeat exposure to homologous C. jejuni strain and assess immune responses associated with protection.
- Conditions
- Campylobacter Infections
- Being tested
- Campylobacter jejuni strains CG8421 and BH-01-0142
- Keywords
- Campylobacter infections
- Medical subject headings
- Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campylobacter jejuni strains CG8421 and BH-01-0142Biological
Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10^6-10^9 CFU
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a safe challenge model of Campylobacter jejuni
Measured: October 2008
Secondary outcomes (1)
Measurement of the human immune response to Campylobacter jejuni infection
Measured: October 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, TD Vaccines A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434798
- Sponsor's protocol ID
- NMRC.2006.0009
- Status last verified
- Jun 2008
- First submitted
- 6 Feb 2007
- Last updated
- 5 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campylobacter Jejuni Challenge Model Development: Dose Ranging Study
- ClinicalTrials.gov ID
- NCT00434798
- Acronym / sponsor ID
- NMRC.2006.0009
- Conditions
- Campylobacter Infections
- Keywords
- Campylobacter infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Naval Medical Research Center, TD Vaccines A/S
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 13 Feb 2007 (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 primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:
- Safe application
- Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
- Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
- Campylobacteriosis attack rate of at least 75%
Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in the newly established human C. jejuni infection model and evaluate short-term (< 3 mo) protection upon repeat exposure to homologous C. jejuni strain and assess immune responses associated with protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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.
Key exclusion criteria (25 listed)
- Presence of a significant medical condition, (e.g. psychiatric conditions or 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 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 strains CG8421 and BH-01-0142Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10^6-10^9 CFU | Biological | – |
Primary outcome
Establish a safe challenge model of Campylobacter jejuni
Time frame: October 2008
1 secondary outcome
Measurement of the human immune response to Campylobacter jejuni infection
Time frame: October 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Campylobacter jejuni strains CG8421 and BH-01-0142 in people with Campylobacter Infections, run by University of Vermont 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 25 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 5 Jun 2008. 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. 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?
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?
Establish a safe challenge model of Campylobacter jejuni (time frame: October 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2008.