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

NCT ID: NCT00716989

Last Updated: 2010-12-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-09-30

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)

Conditions

Healthy; Immunosuppressed

Keywords

Cutaneous immune system; innate immunity; tuberculin skin tests; intradermal vaccination; pathophysiology; Healthy subjects; Immunosuppressed patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Tuberculin antigen

2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Hospices Civils de Lyon

Principal Investigators

Jean-François NICOLAS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

2006.457

Identifier Type: -

Identifier Source: org_study_id