HealthyLBP003NCT00716989
Pathophysiological Study of Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
A study testing Tuberculin antigen in people with Healthy and Immunosuppressed, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Immunosuppressed
- What is being tested?
- Tuberculin antigen
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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)
- Conditions
- Healthy, Immunosuppressed
- Being tested
- Tuberculin antigen
- Keywords
- Cutaneous immune system, innate immunity, tuberculin skin tests, intradermal vaccination, pathophysiology, Healthy subjects, Immunosuppressed patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin antigenBiological
2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 30 minutes, 4 hours or 72 hours
Comparison of changes in the cutaneous immune system between the three groups of subjects
Measured: 30 minutes, 4 hours or 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-François NICOLAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716989
- Sponsor's protocol ID
- 2006.457
- Acronym
- LBP003
- Status last verified
- Dec 2010
- First submitted
- 15 Jul 2008
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections
- ClinicalTrials.gov ID
- NCT00716989
- Acronym / sponsor ID
- LBP003 / 2006.457
- Conditions
- Healthy, Immunosuppressed
- Keywords
- Cutaneous immune system, innate immunity, tuberculin skin tests, intradermal vaccination, pathophysiology, Healthy subjects, Immunosuppressed patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response)
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculin antigen2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum | Biological | – |
Primary outcome
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
2 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
Results and safety
The study was stopped early (reason given: Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François NICOLAS, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuberculin antigen in people with Healthy and Immunosuppressed, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Third group realisation has not been necessary regarding the results of the first two groups (no sufficient modifications in the immune response)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2010; AzTrials last refreshed its copy on 6 Nov 2026.