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

Healthy Clinical Trial

— LBP003  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00716989
• Other study ID #: 2006.457
• Status: Terminated
• Phase: N/A
• First received: July 15, 2008
• Last updated: December 22, 2010
• Start date: November 2008
• Est. completion date: September 2009

Study information

• 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

Clinical Trial 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

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)

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Immunosuppressed

Intervention

Biological:
• Tuberculin antigen
2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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