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

This study has been terminated.
(Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response))
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00716989
First received: July 15, 2008
Last updated: December 22, 2010
Last verified: December 2010
  Purpose

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 Intervention
Healthy
Immunosuppressed
Biological: Tuberculin antigen

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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) [ Time Frame: 30 minutes, 4 hours or 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells [ Time Frame: 30 minutes, 4 hours or 72 hours ] [ Designated as safety issue: No ]
  • Comparison of changes in the cutaneous immune system between the three groups of subjects [ Time Frame: 30 minutes, 4 hours or 72 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Tuberculin antigen
    2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716989

Locations
France
Centre Hospitalier Lyon Sud
Pierre-benite, France, 69 495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-François NICOLAS, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Jean-François NICOLAS, MD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00716989     History of Changes
Other Study ID Numbers: 2006.457
Study First Received: July 15, 2008
Last Updated: December 22, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hospices Civils de Lyon:
Cutaneous immune system
innate immunity
tuberculin skin tests
intradermal vaccination
pathophysiology
Healthy subjects
Immunosuppressed patients

ClinicalTrials.gov processed this record on August 28, 2014