CovicompareG: Evaluation of the Immunogenicity and Safety of Sputnik V and BBIBP-CorV Vaccines for COVID-19 in Adult in Guinea
Study Details
Study Description
Brief Summary
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 or Sputnik V vaccines in 400 adults aged between 18 and 45 years or 55 or older (200 participants for each vaccine), one month after receiving the complete COVID-19 vaccination schedule.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV or Sputnik V vaccines 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.
400 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.
Participants will receive either two doses of BBIBP-CorV at 28 days interval or two doses of Sputnik V at 21 days interval. Vaccines will be administered intramuscular (0.5mL per injection)
Humoral vaccine immune responses, induced by BBIBP-CorV or Sputnik V vaccine will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BBIBP-CorV Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose) |
Biological: BBIBP-CorV
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide
Other Names:
|
| Experimental: Sputnik V Intramuscular administration of the vaccine doses at 21 days (+/- 2 days) interval (0.5 mL/dose) |
Biological: Sputnik V
Human Adenovirus Vector-based COVID19 vaccine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Anti-SARS-CoV-2 Spike IgG level [1 month after complete vaccination schema]
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
Secondary Outcome Measures
- Anti-SARS-CoV-2 specific IgG level [Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24]
Anti-SARS-CoV-2 specific IgG level is measured using ELISA test
- Anti-SARS-CoV-2 IgA and level [Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24]
Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test
- Anti-SARS-CoV-2 IgM level [Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24]
Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test
- Neutralizing antibody level for SARS-CoV-2 [Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24]
Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)
- Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) [Day 0, Month 2, Month 6]
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.
- Mucosal SARS-CoV-2 specific antibody levels [Day 0, Month 1, Month 2, Month 6, Month 12]
Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs
- Epitope profile [Day 0, Month 2]
Determination of epitope profile
- B cell response to vaccine [Day 0, Month 2, Month 6]
Determination of repertoire of B cells (stereotype clonotype)
- Measurement of ultrasensitive IgA and mucosal IgA and IgM functionality [Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24]
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
- Rate of adverse events [Month 1 until Month 24]
Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24
- SARS-CoV-2 infection [Day 0 until Month 24]
Occurrence of confirmed COVID-19 cases during participant follow-up
Other Outcome Measures
- Measurement of specific B memory cells [Day 0, Month 2, Month 6, Month 12]
Measurement of specific B memory cells (Elispot B)
- Measurement of specific T cell response [Day 0, Month 12]
Measurement of specific T cell response (Cytof analysis)
- Identification of predictive determinants of vaccine response [Month 24]
Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype
- Quantitative measures [Day 0 until Month 24]
Quantitative measures: Number of participants recruited, number of follow-up visits carried out, proportion of participants satisfied with the vaccine received
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 45 years old or 55 years and older
-
Be eligible to receive one of the study vaccines as part of the trial
-
Understand and agree to comply with study procedures (visits, telephone calls)
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Agree not to participate in any other vaccine study during the time of the study
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Give written informed consent prior to any examination performed as part of the trial
Exclusion Criteria:
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Age between 46 and 54 years old
-
Positive SARS-CoV-2 antigenic test
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Positive SARS-CoV-2 PCR results less than 48 hours old
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History of infection by COVID-19 confirmed within 3 months prior to inclusion
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Symptoms compatible with COVID-19: sick or febrile participants (body temperature ≥ 38.0°C)
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Pregnant or breastfeeding woman
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Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
-
Anti-coagulant treatment
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Immunosuppressive treatment
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Contraindication to the proposed vaccine (according to RCP)
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Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
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Previously received at least one injection of a SARS-CoV-2 vaccine
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A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
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Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de recherche de Landreah | Conakry | Guinea | ||
| 2 | Palais du Peuple | Conakry | Guinea |
Sponsors and Collaborators
- ANRS, Emerging Infectious Diseases
- CEPI
- Alliance for International Medical Action
- Centre National de Formation et de Recherche en Sante Rurale
- Institut National de la Santé Et de la Recherche Médicale, France
- APHP
- Agence Nationale de Sécurité Sanitaire de la Guinée (ANSS Guinée)
- Innovative clinical research network in vaccinology (IREIVAC)
Investigators
- Study Chair: Odile Launay, Innovative clinical research network in vaccinology (I-REIVAC)
- Principal Investigator: Abdoul Habib Beavogui, Centre National de Formation et de Recherche en Santé Rurale (CNFRSR)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANRS0144S