Healthy Clinical Trial
Official title:
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
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)
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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