COVID-19, Healthy Volunteer, Sars-CoV-2 Infection, Vaccine Adverse Reaction
Conditions
Keywords
BBIBP-CorV, Elderly, SARS CoV 2 infected participants, Safety and immunogenicity
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.
Interventions
BIOLOGICALBBIBP-CorV
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide
Sponsors
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)
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Guinea
Outcome results
None listed