NCT00716989

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Tuberculin antigen	2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-07-16
• Last updated: 2010-12-23

Locations

1 site across 1 country: France