Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
- Conditions
- Vaccine Adverse ReactionCOVID-19Sars-CoV-2 InfectionHealthy Volunteer
- Interventions
- Biological: BBIBP-CorV
- Registration Number
- NCT05409300
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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 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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BBIBP-CorV BBIBP-CorV Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Epitope profile Day 0, Month 2 Determination of epitope profile
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
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
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.
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
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
B cell response to vaccine Day 0, Month 2, Month 6 Determination of repertoire of B cells (stereotype clonotype)
SARS-CoV-2 infection Day 0 until Month 24 Occurrence of confirmed COVID-19 cases during participant follow-up
Trial Locations
- Locations (2)
Centre de recherche de Landreah
🇬🇳Conakry, Guinea
Palais du Peuple
🇬🇳Conakry, Guinea