Status:
UNKNOWN
ACE393-103 Vaccination Challenge Study
Lead Sponsor:
TD Vaccines A/S
Collaborating Sponsors:
SNBL Clinical Pharmacology Center, Inc.
Johns Hopkins University
Conditions:
Campylobacter Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
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 prot...
Eligibility Criteria
Inclusion
- 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 Campylobacter, other bacterial enteric pathogens or intestinal parasites.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00859716
Start Date
October 1 2008
End Date
July 1 2009
Last Update
March 11 2009
Active Locations (1)
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1
Shin Nippon Biomedical Laboratories
Baltimore, Maryland, United States, 21201