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

Condition(s) targeted: Healthy; Immunosuppressed

Intervention: Tuberculin antigen (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Jean-François NICOLAS, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

Overall contact:
Jean-François NICOLAS, MD, Phone: 478 861 572, Ext: 33, Email: jean-francois.nicolas@chu-lyon.fr

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

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

Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment

Primary outcome: 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)

Secondary outcome:

Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells

Comparison of changes in the cutaneous immune system between the three groups of subjects

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)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Jean-François NICOLAS, MD, Phone: 478 861 572, Ext: 33, Email: jean-francois.nicolas@chu-lyon.fr

Centre Hospitalier Lyon Sud, PIERRE-BENITE 69 495, France; Recruiting
Jean-François NICOLAS, MD, Principal Investigator

Starting date: November 2008
Last updated: August 12, 2009