Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine (LabExMI)
|ClinicalTrials.gov Identifier: NCT01699893|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Individuality||Other: unique arm||Not Applicable|
Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another. While the question of variance in human populations continues to be a focal point of scientific research, medical practices and public health policies typically take a 'one size fits all' model to disease management and drug development.
Individual heterogeneity in the immune response can have an enormous impact on the likelihood to respond to therapy or the development of side effects secondary to vaccine administration. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that constitute a healthy immune system and its natural occurring variability.
Efforts to restore the 'personal' in medical care are the current challenge, and the driving vision of the project, to which the current study belongs.
In order to realize the promise of personalized medicine, an in-depth understanding of the determinants of heterogeneity in host response to stress is required.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1012 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: unique arm
Other: unique arm
blood, nasal swab, skin biopsy, stool samples
- Measurement of cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimulators. [ Time Frame: V2 (28days after V1) ]
- Determination of genotype-to-phenotype associations at a mechanistic level [ Time Frame: 4 days after V0 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699893
|Rennes, France, 35042|
|Study Chair:||Matthew ALBERT||Institut Pasteur / Inserm|
|Study Chair:||Lluis QUINTANA-MURCI||Institut Pasteur / CNRS|
|Principal Investigator:||Nicolas FAUCHOUX||Biotrial Rennes|