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COVID-19Phase 2CovicompareGNCT05409300

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

A Phase 2 study testing BBIBP-CorV in people with COVID-19 and Vaccine Adverse Reaction, run by ANRS, Emerging Infectious Diseases at 2 sites in Guinea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
BBIBP-CorV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesGuinea
Study dates
25 Apr 2022to Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Guinea2 sites

  • Centre de recherche de Landreah

    Conakry

  • Palais du Peuple

    Conakry

Other trials in Guinea

About this study

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

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.

Read the 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.

Being tested
BBIBP-CorV
Keywords
BBIBP-CorV, Elderly, SARS CoV 2 infected participants, Safety and immunogenicity
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBIBP-CorVBiological

    Also called Sinopharm

    Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Study groups in NCT05409300
Study groupRoleWhat they receive
BBIBP-CorVExperimentalIntramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)
Receives: Biological: BBIBP-CorV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-SARS-CoV-2 Spike IgG level

    Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test

    Measured: 1 month after complete vaccination schema

Secondary outcomes (11)

  1. Anti-SARS-CoV-2 specific IgG level

    Anti-SARS-CoV-2 specific IgG level is measured using ELISA test

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  2. Anti-SARS-CoV-2 IgA and level

    Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  3. Anti-SARS-CoV-2 IgM level

    Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  4. 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)

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  5. 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.

    Measured: Day 0, Month 2, Month 6

  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

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12

  7. Epitope profile

    Determination of epitope profile

    Measured: Day 0, Month 2

  8. B cell response to vaccine

    Determination of repertoire of B cells (stereotype clonotype)

    Measured: Day 0, Month 2, Month 6

  9. 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

    Measured: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  10. Rate of adverse events

    Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24

    Measured: Month 1 until Month 24

  11. SARS-CoV-2 infection

    Occurrence of confirmed COVID-19 cases during participant follow-up

    Measured: Day 0 until Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start25 Apr 2022
  3. Primary completion3 Aug 2023
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409300
Sponsor's protocol ID
ANRS0144S
Acronym
CovicompareG
Status last verified
Mar 2024
First submitted
28 Mar 2022
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBIBP-CorV in people with COVID-19 and Vaccine Adverse Reaction, run by ANRS, Emerging Infectious Diseases at 2 sites in Guinea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-SARS-CoV-2 Spike IgG level (time frame: 1 month after complete vaccination schema). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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