Clinical trial NCT00716989: Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
Official title: LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Immunosuppressed
Keywords: Cutaneous immune system
innate immunity
tuberculin skin tests
intradermal vaccination
pathophysiology
Healthy subjects
Immunosuppressed patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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: the humoral response is statistically better after intradermic vaccination, compared to intramuscular vaccination, even in target populations such as older subjects or immunosuppressed patients

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 site, 2 physiological serum site and 1 on healthy skin site :

* Group A : healthy young subjects(18 to 40 years old) : 18 subjects
* Sub-group A1 (biopsy 30 minutes after injection) : 6 subjects
* Sub-group A2 (biopsy 4 hours after injection) : 6 subjects
* Sub-group A3 (biopsy 72 hours after injection) : 6 subjects
* Group B : healthy old subjects(60 to 75 years old) : 18 subjects
* Sub-group B1 (biopsy 30 minutes after injection) : 6 subjects
* Sub-group B2 (biopsy 4 hours after injection) : 6 subjects
* Sub-group B3 (biopsy 72 hours after injection) : 6 subjects

Determination of the best time (30 minutes, 4 hours or 72 hours)for intradermal vaccination caracteristics after group A and B data analysis. From these results, last group of immunosuppressed patients performed:Group C with 6 immunosuppressed patients (18 to 60 years old)

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Cellular changes of recruited cells by immunochemical and histological analysis in the three groups of subjects (healthy young subjects, healthy old subjects and immunosuppressed patients)
timeFrame: 30 minutes, 4 hours or 72 hours
Secondary outcomes:
measure: Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells
timeFrame: 30 minutes, 4 hours or 72 hours
measure: Comparison of changes in the cutaneous immune system between the three groups of subjects
timeFrame: 30 minutes, 4 hours or 72 hours
Other outcomes:
Locations:
city: Pierre-benite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François NICOLAS, MD
role: PRINCIPAL_INVESTIGATOR
References: