COVID-19 Clinical Trial
— CoviComMaliOfficial title:
Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali
Verified date | March 2024 |
Source | ANRS, Emerging Infectious Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | March 2025 |
Est. primary completion date | September 25, 2022 |
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: - Positive SARS-CoV-2 antigenic test - Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old - History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion - Symptoms compatible with infection to SARS-CoV-2: 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) - Previously received at least one injection of a SARS-CoV-2 vaccine - Patient having received immunoglobulin or another blood product within 3 months prior to inclusion - 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 |
Country | Name | City | State |
---|---|---|---|
Mali | CVD-MALI | Bamako |
Lead Sponsor | Collaborator |
---|---|
ANRS, Emerging Infectious Diseases | APHP, Center for Vaccine Development - Mali, CEPI, Innovative clinical research network in vaccinology (IREIVAC), Institut National de la Santé Et de la Recherche Médicale, France |
Mali,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measurement of specific B memory cells and T cell response | Measurement of specific B memory cells (Elispot B) and T cell response (Cytof analysis) | B memory cells: Day 0 and then 2,6, and 12 months after inclusion., T cell : Inclusion (D0) and then at 12 months after inclusion | |
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 | Day 0 until 24 months | |
Primary | Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level | Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test | One month after complete vaccination schema | |
Secondary | Anti-SARS-CoV-2 Spike IgG level | Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test | At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion | |
Secondary | Anti-SARS-CoV-2 immunoglobulin M (IgM) level | Anti-SARS-CoV-2 IgM level is measured using ELISA test | At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion | |
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) | Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion | |
Secondary | Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity) | Fluorospot tests (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. | Inclusion (Day 0) and then 2 and 6 months after inclusion | |
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 | Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion | |
Secondary | Determination of Epitope profile | Determination of epitope profile | Day 0 and 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 immunoglobulin A (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 and then 1, 2, 6, 12, and 24 months after inclusion | |
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 | Between month 1 and month 24 after inclusion | |
Secondary | SARS-CoV-2 infection | Occurrence of confirmed COVID-19 cases during participant follow-up | Date of inclusion until 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|