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| Name | Class |
|---|---|
| CEPI | OTHER |
| Alliance for International Medical Action | OTHER |
| Centre National de Formation et de Recherche en Sante Rurale | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBIBP-CorV | Experimental | Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBIBP-CorV | Biological | Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-SARS-CoV-2 Spike IgG level | Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test | 1 month after complete vaccination schema |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-SARS-CoV-2 specific IgG level | Anti-SARS-CoV-2 specific IgG level is measured using ELISA test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of specific B memory cells | Measurement of specific B memory cells (Elispot B) | Day 0, Month 2, Month 6, Month 12 |
| Measurement of specific T cell response | Measurement of specific T cell response (Cytof analysis) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay | Innovative clinical research network in vaccinology (I-REIVAC) | Study Chair |
| Abdoul Habib Beavogui | Centre National de Formation et de Recherche en Santé Rurale (CNFRSR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de Landreah | Conakry | Guinea | ||||
| Palais du Peuple |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722768 | BIBP COVID-19 vaccine |
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| OTHER_GOV |
| APHP | OTHER |
| Agence Nationale de Sécurité Sanitaire de la Guinée (ANSS Guinée) | UNKNOWN |
| Innovative clinical research network in vaccinology (IREIVAC) | UNKNOWN |
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| 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 | 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) | 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. | 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 | Day 0, Month 1, Month 2, Month 6, Month 12 |
| Epitope profile | Determination of epitope profile | Day 0, Month 2 |
| B cell response to vaccine | Determination of repertoire of B cells (stereotype clonotype) | 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 | 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 | Month 1 until Month 24 |
| SARS-CoV-2 infection | Occurrence of confirmed COVID-19 cases during participant follow-up | Day 0 until Month 24 |
| Day 0, Month 12 |
| Identification of predictive determinants of vaccine response | Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype | Month 24 |
| Quantitative measures | Quantitative measures: Number of participants recruited, number of follow-up visits carried out, proportion of participants satisfied with the vaccine received | Day 0 until Month 24 |
| Conakry |
| Guinea |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |