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

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

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

Study Overview

• Status: Terminated
• Conditions: Healthy; Immunosuppressed
• Intervention / Treatment: Biological: Tuberculin antigen

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-benite, France, 69 495
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-François NICOLAS, MD, Hospices civils de Lyon

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 23, 2010
• Last Update Submitted That Met QC Criteria: December 22, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Healthy subjects; pathophysiology; innate immunity; intradermal vaccination; Cutaneous immune system; tuberculin skin tests; Immunosuppressed patients
• Other Study ID Numbers: 2006.457