Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea

Conditions
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COVID-19, Vaccine Adverse Reaction, Sars-CoV-2 Infection, Healthy Volunteer

Intervention / Treatment
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* Biological: BBIBP-CorV


Participation Criteria
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Eligibility Criteria
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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) Agree not to participate in any other vaccine study during the time of the study Give written informed consent prior to any examination performed as part of the trial Exclusion Criteria: Age between 46 and 54 years old Positive SARS-CoV-2 antigenic test Positive SARS-CoV-2 PCR results less than 48 hours old History of infection by COVID-19 confirmed within 3 months prior to inclusion Symptoms compatible with COVID-19: sick or febrile participants (body temperature ≥ 38.0°C) Pregnant or breastfeeding woman 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 Immunosuppressive treatment Contraindication to the proposed vaccine (according to RCP) Patient having received immunoglobulin or another blood product within 3 months prior to inclusion Previously received at least one injection of a SARS-CoV-2 vaccine 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBIBP-CorV<br>Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose) | Biological: BBIBP-CorV<br>* Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide<br>* Other names: Sinopharm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BBIBP-CorV, Elderly, SARS CoV 2 infected participants, Safety and immunogenicity