Healthy Clinical Trial
— LBP003Official title:
LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
Verified date | December 2010 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Direction Générale de la Santé |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 36 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Lyon Sud | Pierre-benite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells | 30 minutes, 4 hours or 72 hours | No | |
Secondary | Comparison of changes in the cutaneous immune system between the three groups of subjects | 30 minutes, 4 hours or 72 hours | No |
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