A Phase 2 interventional study of BBIBP-CorV in COVID-19, Vaccine Adverse Reaction and Sars-CoV-2 Infection, sponsored by ANRS, Emerging Infectious Diseases. Active, not recruiting at 2 sites in Guinea. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Prevention
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 200 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)
Biological: BBIBP-CorV
Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide
Also known as: Sinopharm
Anti-SARS-CoV-2 Spike IgG level
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
Time frame: 1 month after complete vaccination schema
Anti-SARS-CoV-2 specific IgG level
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
Anti-SARS-CoV-2 IgA and level
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
Anti-SARS-CoV-2 IgM level
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
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)
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
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.
Time frame: Day 0, Month 2, Month 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
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12
Epitope profile
Determination of epitope profile
Time frame: Day 0, Month 2
B cell response to vaccine
Determination of repertoire of B cells (stereotype clonotype)
Time frame: Day 0, Month 2, Month 6
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
Time frame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
Rate of adverse events
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
SARS-CoV-2 infection
Occurrence of confirmed COVID-19 cases during participant follow-up
Time frame: Day 0 until Month 24
Measurement of specific B memory cells
Measurement of specific B memory cells (Elispot B)
Time frame: Day 0, Month 2, Month 6, Month 12
Measurement of specific T cell response
Measurement of specific T cell response (Cytof analysis)
Time frame: Day 0, Month 12
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
Time frame: Month 24
Quantitative measures
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
Plan to share: Yes
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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