Clinical trial NCT02660723: Impact of Aging on Cytokine Production by Innate Immune Cells
Official title: To Investigate the Impact of Aging on Cytokine and Chemokine Production by Peripheral Blood Immune Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: M01.774.500
Volunteers
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main goal of this study is to investigate the impact of aging on the responsiveness of peripheral blood immune cells. To this aim, the investigators will take advantage of a recently described syringe-based assay system that can reproducibly assess induced, innate or adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to this study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A total of 14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C), R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at 37°C, cellular supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery multiplexing platform.


Eligibility criteria: Inclusion Criteria:

* volunteers will be invited to settle an appointment with the Nice University Hospital (CHU de Nice) Research Clinical Center (CRC).
* being between 18 and 30 year-old (group Y) or being older than 55 year-old (group O),
* ability to understand and speak French,
* being registered at the Social Security,
* acceptance to be serologically tested for HIV and HVC,
* considered healthy based on both past medical records and the clinical examination performed at the inclusion visit,
* exhibiting a body mass index (body mass divided by the square of their height) comprised between 18.5 and 30.0 kg/m2.

Exclusion Criteria:

* having participated to a drug clinical trial since less than 3 months,
* having traveled to a tropical or a sub-tropical country over the past 3 months,
* being pregnant or a lactating mother (for women),
* having performed intensive physical exercise over the past 12 hours,
* following a specific diet for medical reasons,
* over-drinking, i.e. more that 50 g of pure alcohol every day,
* having taken an immuno-suppressive or immuno-modulatory drug over the past two weeks, or for at least 14 consecutive days over the past 6 months,
* having been vaccinated over the past 3 months,
* declaring not being on an empty stomach for less than 12 hours,
* having received a blood transfusion or intravenous immunoglobulins over the past 3 months,
* declaring being HIV- or HVC- positive,
* having suffered from an infection since less than 3 weeks,
* exhibiting a positive urine pregnancy test at the inclusion visit,
* suffering from a severe/chronic/relapsing pathology, i.e. inflammatory bowel disease, psoriasis, atopic dermatitis, rheumatoid arthritis, multiple sclerosis, type I or type II diabetes, Parkinson's disease, and (p) having been diagnosed with a cancer and not being in a remitting period for less than 5 years.

Primary outcomes:
measure: CCL2 levels
timeFrame: at first day
Secondary outcomes:
measure: Other CCL levels
timeFrame: at first day
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Passeron Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References: