Status:
TERMINATED
Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Healthy
Immunosuppressed
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of the vaccination is to induce humoral (antibody) and intracellular (T lymphocyte) responses. Various data show that intradermal vaccination is more efficient than intramuscular vaccination:...
Detailed Description
Realisation of 2 groups of healthy subjects with 2 intradermal injection of 50 µl of tuberculin + 2 intradermal injection of 50 µl of physiological serum. 5 biopsy performed on 2 Tuberculin injection ...
Eligibility Criteria
Inclusion
- Both genders eligible for study.
- Female participants must use a contraceptive method.
- Tuberculin skin test between 1 and 15mm
- Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
- Subjects registered in a social security system or with health insurance cover
- First group: Healthy subjects aged from 18 to 75 years with 2 subgroups: 18-40 and 60-75 year old subjects
- Second group: Patients with kidney transplants of longer than 6 months on immunosuppressive treatment
Exclusion
- Pregnant or lactating women.
- Previous allergic reaction to tuberculin skin test
- Active skin disease on testing zone
- Patients with a clinically significant disease (chronic, recurrent or active)
- Local or systemic medication which interacts with the outcome measures.
- Patients deprived of their civic rights, in custody, or under the care of a tutorial, judiciary or administrative body.
- Patients relevant of a protection measure
- Patients in a critical medical situation
- Patients with a personal situation evaluated by the investigator as unable to give an optimal participation in the study, or where it could constitute a risk for the patient
- Linguistic barrier or psychological profile disabling the patient from signing the consent form
- Patient still in an exclusion period following participation in another clinical trial
- Patients having earned more than 4500€ in indemnities following participation in clinical trials during the last 12 months, including this study
- For group 1 only:
- Systemic corticotherapy or immunosuppressive treatment within the 2 weeks before first visit or within 2 weeks before the third visit or the biopsies.
- Systemic non anti-inflammatory drugs the week before the first visit or within 1 week before the third visit or the biopsies
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00716989
Start Date
November 1 2008
End Date
September 1 2009
Last Update
December 23 2010
Active Locations (1)
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1
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69 495