---
title: Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
nct_id: NCT00716989
overall_status: TERMINATED
phase: NA
sponsor: Hospices Civils de Lyon
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00716989.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00716989"
ct_last_update_post_date: 2010-12-23
last_seen_at: "2026-05-12T06:50:39.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections

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

**NCT ID:** [NCT00716989](https://clinicaltrials.gov/study/NCT00716989)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response)
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Hospices Civils de Lyon
- **Conditions:** Healthy, Immunosuppressed
- **Start Date:** 2008-11
- **Completion Date:** 2009-09
- **CT.gov Last Update:** 2010-12-23

## 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

## 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)

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Interventions

- **Tuberculin antigen** (BIOLOGICAL) — 2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum

## Primary Outcomes

- **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)** _(time frame: 30 minutes, 4 hours or 72 hours)_

## Secondary Outcomes

- **Molecular analysis of cytokines and chemokines involved in recruitment and/or function of immunocompetent cells** _(time frame: 30 minutes, 4 hours or 72 hours)_
- **Comparison of changes in the cutaneous immune system between the three groups of subjects** _(time frame: 30 minutes, 4 hours or 72 hours)_

## Locations (1)

- Centre Hospitalier Lyon Sud, Pierre-Bénite, France

## Recent Field Changes (last 30 days)

- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier lyon sud|pierre-bénite||france` — added _(2026-05-12)_

---

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