Back to resultsEvaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea (CovicompareG)
Primary Purpose
COVID-19, Vaccine Adverse Reaction, Sars-CoV-2 Infection
Status
Recruiting
Phase
Phase 2
Locations
Guinea
Study Type
Interventional
Intervention
BBIBP-CorV
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring BBIBP-CorV, Elderly, SARS CoV 2 infected participants, Safety and immunogenicity
Eligibility 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)
- 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
Sites / Locations
- Centre de recherche de Landreah
- Palais du PeupleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BBIBP-CorV
Arm Description
Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)
Outcomes
Primary Outcome Measures
Anti-SARS-CoV-2 Spike IgG level
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
Secondary Outcome Measures
Anti-SARS-CoV-2 specific IgG level
Anti-SARS-CoV-2 specific IgG level is measured using ELISA test
Anti-SARS-CoV-2 IgA and level
Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test
Anti-SARS-CoV-2 IgM level
Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test
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)
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.
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
Epitope profile
Determination of epitope profile
B cell response to vaccine
Determination of repertoire of B cells (stereotype clonotype)
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
Rate of adverse events
Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24
SARS-CoV-2 infection
Occurrence of confirmed COVID-19 cases during participant follow-up
Full Information
NCT ID
NCT05409300
First Posted
March 28, 2022
Last Updated
February 15, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
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)
1. Study Identification
Unique Protocol Identification Number
NCT05409300
Brief Title
Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
Acronym
CovicompareG
Official Title
Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Vaccine Adverse Reaction, Sars-CoV-2 Infection, Healthy Volunteer
Keywords
BBIBP-CorV, Elderly, SARS CoV 2 infected participants, Safety and immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BBIBP-CorV
Arm Type
Experimental
Arm Description
Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)
Intervention Type
Biological
Intervention Name(s)
BBIBP-CorV
Other Intervention Name(s)
Sinopharm
Intervention Description
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide
Primary Outcome Measure Information:
Title
Anti-SARS-CoV-2 Spike IgG level
Description
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
Time Frame
1 month after complete vaccination schema
Secondary Outcome Measure Information:
Title
Anti-SARS-CoV-2 specific IgG level
Description
Anti-SARS-CoV-2 specific IgG level is measured using ELISA test
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Title
Anti-SARS-CoV-2 IgA and level
Description
Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Title
Anti-SARS-CoV-2 IgM level
Description
Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Title
Neutralizing antibody level for SARS-CoV-2
Description
Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Title
Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)
Description
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.
Time Frame
Day 0, Month 2, Month 6
Title
Mucosal SARS-CoV-2 specific antibody levels
Description
Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12
Title
Epitope profile
Description
Determination of epitope profile
Time Frame
Day 0, Month 2
Title
B cell response to vaccine
Description
Determination of repertoire of B cells (stereotype clonotype)
Time Frame
Day 0, Month 2, Month 6
Title
Measurement of ultrasensitive IgA and mucosal IgA and IgM functionality
Description
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
Time Frame
Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Title
Rate of adverse events
Description
Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24
Time Frame
Month 1 until Month 24
Title
SARS-CoV-2 infection
Description
Occurrence of confirmed COVID-19 cases during participant follow-up
Time Frame
Day 0 until Month 24
Other Pre-specified Outcome Measures:
Title
Measurement of specific B memory cells
Description
Measurement of specific B memory cells (Elispot B)
Time Frame
Day 0, Month 2, Month 6, Month 12
Title
Measurement of specific T cell response
Description
Measurement of specific T cell response (Cytof analysis)
Time Frame
Day 0, Month 12
Title
Identification of predictive determinants of vaccine response
Description
Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype
Time Frame
Month 24
Title
Quantitative measures
Description
Quantitative measures: Number of participants recruited, number of follow-up visits carried out, proportion of participants satisfied with the vaccine received
Time Frame
Day 0 until Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inmaculada Ortega Pérez
Phone
+33 1 82 53 33 34
Email
inmaculada.ortega-perez@anrs.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Dublineau
Phone
+33 1 42 34 83 75
Email
amelie.dublineau@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay
Organizational Affiliation
Innovative clinical research network in vaccinology (I-REIVAC)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdoul Habib Beavogui
Organizational Affiliation
Centre National de Formation et de Recherche en Santé Rurale (CNFRSR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de Landreah
City
Conakry
Country
Guinea
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdoul Habib Beavogui
Phone
+224 628 04 53 52
Facility Name
Palais du Peuple
City
Conakry
Country
Guinea
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdoul Habib Beavogui
Phone
+224628045352
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
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