Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.
The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, comparing younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included. 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. Participants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection) Humoral vaccine immune responses, induced by BBIBP-CorV will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide
Centre de recherche de Landreah
Conakry, Guinea
Palais du Peuple
Conakry, Guinea
Anti-SARS-CoV-2 Spike IgG level
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
Time frame: 1 month after complete vaccination schema
Anti-SARS-CoV-2 specific IgG level
Anti-SARS-CoV-2 specific IgG level is measured using ELISA test
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Anti-SARS-CoV-2 IgA and level
Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Anti-SARS-CoV-2 IgM level
Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
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: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)
Fluorospot tests (Type 1,2,17 helper T cell (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: Day 0, Month 2, Month 6
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
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Time frame: Day 0, Month 1, Month 2, Month 6, Month 12
Epitope profile
Determination of epitope profile
Time frame: Day 0, 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 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, Month 1, Month 2, Month 6, Month 12, and Month 24
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: Month 1 until Month 24
SARS-CoV-2 infection
Occurrence of confirmed COVID-19 cases during participant follow-up
Time frame: Day 0 until Month 24