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

NCT00716989 | Terminated DMC

• 1 other identifier: 2006.457
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy; Immunosuppressed

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells

  30 minutes, 4 hours or 72 hours

• Comparison of changes in the cutaneous immune system between the three groups of subjects

  30 minutes, 4 hours or 72 hours

Interventions

Tuberculin antigen BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69 495, France

Location

Study Officials

• Jean-François NICOLAS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 23, 2010

Record last verified: 2010-12

Locations

FR (1)