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

COVID-19 Clinical Trial

— CovicompareG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05409300
• Other study ID #: ANRS0144S
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 25, 2022
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• BBIBP-CorV
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Locations

Country	Name	City	State
Guinea	Centre de recherche de Landreah	Conakry
Guinea	Palais du Peuple	Conakry

Sponsors (8)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Agence Nationale de Sécurité Sanitaire de la Guinée (ANSS Guinée), Alliance for International Medical Action, APHP, Centre National de Formation et de Recherche en Sante Rurale, CEPI, Innovative clinical research network in vaccinology (IREIVAC), Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of specific B memory cells	Measurement of specific B memory cells (Elispot B)	Day 0, Month 2, Month 6, Month 12
Other	Measurement of specific T cell response	Measurement of specific T cell response (Cytof analysis)	Day 0, Month 12
Other	Identification of predictive determinants of vaccine response	Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype	Month 24
Other	Quantitative measures	Quantitative measures: Number of participants recruited, number of follow-up visits carried out, proportion of participants satisfied with the vaccine received	Day 0 until Month 24
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Epitope profile	Determination of epitope profile	Day 0, Month 2
Secondary	B cell response to vaccine	Determination of repertoire of B cells (stereotype clonotype)	Day 0, Month 2, Month 6
Secondary	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
Secondary	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
Secondary	SARS-CoV-2 infection	Occurrence of confirmed COVID-19 cases during participant follow-up	Day 0 until Month 24