Status:
COMPLETED
Cholera Toxin B Subunit (CTB) Administered by Mucosal Way in Healthy Adult Volunteer
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
It is a biomedical research without direct individual benefit, exploring and comparing the mucosal immune response after oral, nasal and sublingual administration of B-subunit of non-toxic cholera tox...
Detailed Description
The immense majority of the infections involve the mucosal surfaces as a gateway of the pathogenic agent. These mucosal surfaces are mainly represented by the gastrointestinal, respiratory and urogeni...
Eligibility Criteria
Inclusion
- Adult male between 18 and 50 years,
- Adult female aged 18 to 50 years under oral contraception (pill) for at least 6 months, or IUD for at least 6 under, and agreeing to carry out a pregnancy test during the initial clinical visit
- Affiliate or entitled to Social Security
- Signing the informed consent of the volunteer
Exclusion
- Seropositive patient for HIV, Hepatitis B, Hepatitis C (oral questioning)
- Pregnant Woman, parturient or breast-feeding
- News hospitalized for other reasons that the research
- Minor, Major under supervision
- Participation in a current or recent study or at present in period of exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00820144
Start Date
April 1 2006
End Date
February 1 2007
Last Update
January 12 2009
Active Locations (1)
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1
Laboratoire d'anatomo-pathologie, hôpital Pasteur
Nice, France, 06000