NCT02660723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

November 30, 2015

Last Update Submit

July 20, 2018

Conditions

Healthy

Keywords

M01.774.500Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Other CCL levels

    at first day

Study Arms (1)

Healthy Volunteers

OTHER

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.

Other: Healthy Volunteers

Interventions

Healthy VolunteersOTHER

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.

Also known as: blood test
Healthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • exhibiting a body mass index (body mass divided by the square of their height) comprised between 18.5 and 30.0 kg/m2.

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière

Nice, Alpes-Maritimes, 06200, France

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Passeron Thierry, PhD

    CHU de Nice, Service de Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

January 21, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

June 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)