Campylobacter InfectionPhase 2ACE393-103VCNCT00859716
ACE393-103 Vaccination Challenge Study
A Phase 2 study testing ACE393 in people with Campylobacter Infection, run by TD Vaccines A/S at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Infection
- What is being tested?
- ACE393
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2009
- Phase
- Phase 2
- 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.
- General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor.
- Negative serum pregnancy test at screening.
Who cannot join
- Immunosuppressive illness or clinically significant IgA deficiency.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Evidence of inflammatory arthritis on examination and/or HLA-B27 positive.
- Allergy or prior intolerance to selected antibiotics (specified in the protocol)
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; or passing of loose or liquid stools other than on an occasional basis.
- History of diarrhea.
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- Stool culture positive for Campylobacter, other bacterial enteropathogens and intestinal parasites.
- History of microbiologically confirmed Campylobacter infection.
- History of vaccination for or ingestion of Campylobacter.
- Immunologic evidence of Campylobacter exposure
- Serologic evidence of prior Campylobacter infection.
- Cell mediated immune response evidence of prior Campylobacter infection.
- Fever within 48 hours preceding challenge.
- Presence of any signs or symptoms indicative of active infection.
- Diarrhea occurring in the 7 days prior to challenge.
- Stool culture positive for Campylobacter, other bacterial enteric pathogens or intestinal parasites.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shin Nippon Biomedical Laboratories
Baltimore, Maryland, 21201
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Vaccination-Challenge Study of ACE393 to Determine Efficacy Against the Symptoms of Moderate to Severe Campylobacter Jejuni Infection in Normal Healthy Volunteers
The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.
Read the detailed description
This study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior C.jejuni infections or immunity, will be vaccinated with ACE393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with C.jejuni. The study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ACE393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with C.jejuni. During the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). Criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. All volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). Discharge criteria are predefined. Post-discharge follow-up will further monitor safety, confirm C .jejuni eradication after antibiotic therapy, and assess immunologic response.
- Conditions
- Campylobacter Infection
- Being tested
- ACE393, Placebo vaccine
- Keywords
- Vaccination, Diarrhea, Traveler's Diarrhea, Campylobacter jejuni, C. jejuni, Campylobacter, Campy
- Medical subject headings
- Campylobacter Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE393Biological
Also called Campylobacter jejuni
ACE393 250 micrograms as intra muscular injection at day 0 and day 21
Placebo vaccineBiological
Also called Campylobacter jejuni
Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | vaccination with ACE393 followed by challenge with campylobacter jejuni Receives: Biological: ACE393 |
| 2 | Placebo comparator | Placebo vaccination followed by challenge with campylobacter jejuni Receives: Biological: Placebo vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Moderate or Severe Diarrhea
Measured: 20 weeks
Secondary outcomes (4)
Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)
Measured: 20 Weeks
Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)
Measured: 20 weeks
Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)
Measured: 20 weeks
Incidence of severe diarrhea
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Campylobacter InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TD Vaccines A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SNBL Clinical Pharmacology Center, Inc., Johns Hopkins University, University of Vermont, SGS U.S. Testing Company Inc., Fulcrum Pharma (Europe) Ltd
- Investigators
- Mohamed Al-Ibrahim, MD, Principal investigator, Shin Nippon Biomedical Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859716
- Sponsor's protocol ID
- ACE393-103
- Other IDs
- BB013742
- Acronym
- ACE393-103VC
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2009
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Vaccination-Challenge Study of ACE393 to Determine Efficacy Against the Symptoms of Moderate to Severe Campylobacter Jejuni Infection in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00859716
- Acronym / sponsor ID
- ACE393-103VC / ACE393-103
- Conditions
- Campylobacter Infection
- Keywords
- Vaccination, Diarrhea, Traveler's Diarrhea, Campylobacter jejuni, C. jejuni, Campylobacter, Campy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- TD Vaccines A/SIndustry (pharma, biotech, devices)
- Collaborators
- SNBL Clinical Pharmacology Center, Inc., Johns Hopkins University, University of Vermont, SGS U.S. Testing Company Inc., Fulcrum Pharma (Europe) Ltd
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 11 Mar 2009 (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 purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.
Detailed description
This study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior C.jejuni infections or immunity, will be vaccinated with ACE393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with C.jejuni. The study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ACE393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with C.jejuni. During the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). Criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. All volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). Discharge criteria are predefined. Post-discharge follow-up will further monitor safety, confirm C .jejuni eradication after antibiotic therapy, and assess immunologic response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ACE393vaccination with ACE393 followed by challenge with campylobacter jejuni |
| 2 | Placebo comparator | Biological: Placebo vaccinePlacebo vaccination followed by challenge with campylobacter jejuni |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female between 18 and 50 years of age.
- General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor.
- Negative serum pregnancy test at screening.
Key exclusion criteria (16 listed)
- Immunosuppressive illness or clinically significant IgA deficiency.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Evidence of inflammatory arthritis on examination and/or HLA-B27 positive.
- Allergy or prior intolerance to selected antibiotics (specified in the protocol)
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; or passing of loose or liquid stools other than on an occasional basis.
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 |
|---|---|---|
| ACE393Also: Campylobacter jejuniACE393 250 micrograms as intra muscular injection at day 0 and day 21 | Biological | 1 |
| Placebo vaccineAlso: Campylobacter jejuniPlacebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21 | Biological | 2 |
Primary outcome
Incidence of Moderate or Severe Diarrhea
Time frame: 20 weeks
4 secondary outcomes
Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)
Time frame: 20 Weeks
Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)
Time frame: 20 weeks
Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)
Time frame: 20 weeks
Incidence of severe diarrhea
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
- SponsorLink provided by the sponsor.
Related trials for Campylobacter Infection
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.
Mohamed Al-Ibrahim, MD principal investigator
Shin Nippon Biomedical Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACE393 in people with Campylobacter Infection, run by TD Vaccines A/S 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 3 inclusion and 16 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 11 Mar 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of Moderate or Severe Diarrhea (time frame: 20 weeks). 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 11 Mar 2009.