Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines. Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL. Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein
CVD-MALI
Bamako, Mali
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level
Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
Time frame: One month after complete vaccination schema
Anti-SARS-CoV-2 Spike IgG level
Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
Time frame: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Anti-SARS-CoV-2 immunoglobulin M (IgM) level
Anti-SARS-CoV-2 IgM level is measured using ELISA test
Time frame: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Neutralizing antibody level for SARS-CoV-2
Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)
Time frame: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)
Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen-specific T cells by mass cytometry at Day 0 and Month 6 selected from the results of the Fluorospot test.
Time frame: Inclusion (Day 0) and then 2 and 6 months after inclusion
Mucosal SARS-CoV-2 specific antibody levels
Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs
Time frame: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Determination of Epitope profile
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Determination of epitope profile
Time frame: Day 0 and Month 2
B cell response to vaccine
Determination of repertoire of B cells (stereotype clonotype)
Time frame: Day 0, Month 2, Month 6
Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality
Measurement of ultrasensitive IgA in saliva by Photoring assay Measurement of mucosal IgA and IgM functionality by SARS-CoV-2 mucosal IgA- and IgM-specific antibody-dependent cell-mediated cytotoxicity (ADCC) test
Time frame: Day 0 and then 1, 2, 6, 12, and 24 months after inclusion
Rate of adverse events
Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24
Time frame: Between month 1 and month 24 after inclusion
SARS-CoV-2 infection
Occurrence of confirmed COVID-19 cases during participant follow-up
Time frame: Date of inclusion until 24 months