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

Study Overview
=================
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.

Official Title
-----------------
A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: No study treatments administered


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signature of an informed consent; Male or female between 18 and 60 years of age. Exclusion Criteria: Positive serology for hepatitis B or C or HIV; Acute infection at inclusion; 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 25 healthy volunteers<br>No study treatments administered | Other: No study treatments administered<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers and reverse transcriptase activity in blood. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis (MS), Multiple Sclerosis associated RetroVirus (MSRV), MSRV envelop protein (MSRV-Env), Temelimab