This study aims to evaluate the immunogenicity of Moderna mRNA-1273 vaccine in volunteers aged 65 years or more compared to volunteers aged 18-45 years, over 24 months duration. It will provide necessary data on the early immunological response to the vaccine and its evolution in quantitative and qualitative terms. This study will allow establishing how aging influences the response to the vaccine and help to adapt the vaccinal plan. For instance it will suggest the necessity of a vaccination booster.
Phase II, comparative, non-randomized trial assessing the immunogenicity and safety of vaccine candidate Moderna-1273 against SARS-CoV-2. A total of 180 volunteers will be included and vaccinated (2 doses, at day 1 and day 29), divided in 3 groups (60 volunteers 18 - 45 years old, 60 volunteers 65 - 74 years old, 60 volunteers at least 75 years old). Vaccinated volunteers of the three arms will be immune-monitored during 24 months via a battery of in vitro and ex vivo tests to comprehensively assess the course of humoral, cellular and mucosal immunity over time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
SARS-CoV-2 vaccine
Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera
Anti-SARS-CoV-2 Spike specific IgG Immunity acquisition
Time frame: Day 57 (28 days after second injection of mRNA-1273)
Anti SARS-CoV -2 IgG, IgA and IgM (total and subclasses IgG1-4) as measured by ELISA.
Assessment of humoral immunity-systemic response
Time frame: From Day 1 to Month 24
Anti-SARS-CoV-2 neutralizing antibody (in vitro neutralisation assay.
Assessment of humoral immunity-systemic response
Time frame: From Day 1 to Month 24
Anti-SARS-CoV-2 -specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins.
Assessment of humoral immunity-systemic response
Time frame: From Day 1 to Month 24
Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of antigen specific T-Cells via Mass cytometry, B cell repertoire and memory
Assessment of cellular immunity acquisition
Time frame: From Day 1 to Month 24
Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.
Assessment of mucosal immunity
Time frame: From Day 1 to Month 24
Functionality of mucosal sIgA and sIgM by Antibody Dependent Cellular Cytotoxicity (ADCC) assay specific for SARS-CoV-2 mucosal IgA and IgM
Assessment of mucosal immunity
Time frame: From Day 1 to Month 24
Local and systemic reactogenicity
Clinical safety evaluation
Time frame: From Day 1 to Month 24
Determination of autoimmunity markers such as antibodies Anti-nuclear (unit measure: titers)
Biological safety evaluation
Time frame: From Day 1 to Month 24
Determination of autoimmunity markers such as antibodies Anti-ACL, Anti-β2-GP1, Rheumatoid factor (unit measure: U/L)
Biological safety evaluation
Time frame: From Day 1 to Month 24
Determination of autoimmunity markers such as antibodies Anti-GM1, Anti-MAG ( unit measure: pos/ne)
Biological safety evaluation
Time frame: From Day 1 to Month 24
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