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 range18 Years – 50 Years
SexALL
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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…