CoviCompMali: Evaluation of the Immunogenicity and Safety of COVID-19 Vaccines (Ad26.COV2.S and NVX-CoV2373)
Study Details
Study Description
Brief Summary
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 and NVX-CoV2373 vaccines in 400 adults (200 participants for each vaccine), one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S or NVX-CoV2373 vaccines in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.
400 participants will be included, 200 participants for each vacine. 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.
Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants
NVX-CoV2373 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants
Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.
Participants in NVX-CoV2373 arm receive 2 doses intramuscularly, the second dose 21 days apart, 0.5mL each.
Humoral vaccine immune responses, induced by Ad26.COV2.S and NVX-CoV2373 vaccines, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ad26.COV2.S Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S. |
Biological: Ad26.COV2.S
Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein
Other Names:
|
| Experimental: NVX-CoV2373 Two doses (0.5mL) of SARS-CoV-2 vaccine NVX-CoV2373, the second dose administered 21 (+/-2 days) days after the first dose. |
Biological: NVX-CoV2373
Recombinant, adjuvanted vaccine, contains SARS-CoV-2 spike protein adjuvanted with Matrix-M
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level [One month after complete vaccination schema]
Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
Secondary Outcome Measures
- Anti-SARS-CoV-2 Spike IgG level [At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion]
Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
- Anti-SARS-CoV-2 immunoglobulin M (IgM) level [At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion]
Anti-SARS-CoV-2 IgM level is measured using ELISA test
- Neutralizing antibody level for SARS-CoV-2 [Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion]
Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)
- Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity) [Inclusion (Day 0) and then 2 and 6 months after inclusion]
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.
- Mucosal SARS-CoV-2 specific antibody levels [Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion]
Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs
- Determination of Epitope profile [Day 0 and Month 2]
Determination of epitope profile
- B cell response to vaccine [Day 0, Month 2, Month 6]
Determination of repertoire of B cells (stereotype clonotype)
- Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality [Day 0 and then 1, 2, 6, 12, and 24 months after inclusion]
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 [Between month 1 and month 24 after inclusion]
Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24
- SARS-CoV-2 infection [Date of inclusion until 24 months]
Occurrence of confirmed COVID-19 cases during participant follow-up
Other Outcome Measures
- Measurement of specific B memory cells and T cell response [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]
Measurement of specific B memory cells (Elispot B) and T cell response (Cytof analysis)
- Identification of predictive determinants of vaccine response [Day 0 until 24 months]
Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype
Eligibility Criteria
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)
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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:
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Positive SARS-CoV-2 antigenic test
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Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
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History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
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Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
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Pregnant or breastfeeding woman
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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)
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Anti-coagulant treatment
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Immunosuppressive treatment
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Contraindication to the proposed vaccine (according to RCP)
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Previously received at least one injection of a SARS-CoV-2 vaccine
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Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CVD-MALI | Bamako | Mali | 251 |
Sponsors and Collaborators
- ANRS, Emerging Infectious Diseases
- CEPI
- Innovative clinical research network in vaccinology (IREIVAC)
- Institut National de la Santé Et de la Recherche Médicale, France
- APHP
- Center for Vaccine Development - Mali
Investigators
- Study Chair: Odile Launay, Innovative clinical research network in vaccinology (I-REIVAC)
- Principal Investigator: Samba Sow, Center for Vaccine Development-Mali (CVD-Mali)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANRS0142S