Impact of Aging on Cytokine Production by Innate Immune Cells

Healthy Clinical Trial

— Cytokinage  

Official title:

To Investigate the Impact of Aging on Cytokine and Chemokine Production by Peripheral Blood Immune Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660723
• Other study ID #: 15-PP-07
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2018

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Healthy Volunteers
A catheter will be introduced in the arm vein and 14 ml of blood will be drawn in one 4 ml dry tube, one 5 ml heparinized tube for cell count and 5 1 ml TruCulture tubes.

Locations

Country	Name	City	State
France	CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCL2 levels	Compare CCL2 levels in the supernatants of poly(I :C)-stimulated whole blood cells between volunteers aged from 18 to 30 years and volunteers older than 55	at first day
Secondary	Other CCL levels	Compare CXCL8 (IL-8) levels in the supernatants of poly(I :C)-stimulated whole blood cells between volunteers aged from 18 to 30 years and volunteers older than 55	at first day