Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population

NCT01804660 | Completed

• 1 other identifier: GN-E-003
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis (MS); Multiple Sclerosis associated RetroVirus (MSRV); MSRV envelop protein (MSRV-Env); Temelimab

Outcome Measures

Primary Outcomes (1)

• Establish a control value for the levels of MSRV expression in the normal population over time

  Establish a control value for the levels of MSRV expression in the normal population over time using 3 approaches: * MSRV transcripts in PBMC; * MSRV transcripts in plasma; * MSRV-Env protein in serum.

  1 year

Secondary Outcomes (1)

• Inflammatory markers and reverse transcriptase activity in blood.

  1 year

Study Arms (1)

25 healthy volunteers

No study treatments administered

Other: No study treatments administered

Interventions

No study treatments administered OTHER

25 healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Blood donors coming for regular blood draw in the center of transfusion.

You may qualify if:

• Signature of an informed consent;
• Male or female between 18 and 60 years of age.

You may not qualify if:

• Positive serology for hepatitis B or C or HIV;
• Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;
• Pregnancy or breastfeeding;
• Heavy smokers i.e. more than 10 cigarettes per day;
• History of alcohol or drug abuse in the last 3 years;
• Participation in a clinical trial (within the last 3 months).

Sponsors & Collaborators

• GeNeuro Innovation SAS: lead

Study Sites (1)

Etablissement Français du Sang Rhône Alpes - 1 route de Taninges

Annemasse, 74100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and PBMC.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 5, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 20, 2020

Record last verified: 2018-02

Locations

FR (1)