ACE393-103 Vaccination Challenge Study (NCT00859716) | Clinical Trial Compass
UnknownPhase 2
ACE393-103 Vaccination Challenge Study
United States72 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria (selected):
* 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.
Exclusion Criteria (selected):
* 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.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.