LBP003: Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT00716989

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Immunosuppressed	Biological: Tuberculin antigen	N/A

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

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) [30 minutes, 4 hours or 72 hours]

Secondary Outcome Measures

Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells [30 minutes, 4 hours or 72 hours]
Comparison of changes in the cutaneous immune system between the three groups of subjects [30 minutes, 4 hours or 72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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