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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003547-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| Bioster, a.s. | INDUSTRY |
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Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.
In addition, the reactogenicity following the vaccine, remains important with COVID-19 vaccines, whether using an Messenger RiboNucleic Acid (mRNA) technique or an adenovirus vector technique. A better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. There are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of COVID-19 and the type of vaccine administered. A better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk COVID-19 population.
Thus, in partnership with Sanofi Pasteur and Bioaster, the Group On Mucosal Immunity And Pathogens (GIMAP) and Circulating Immune Complexes (CIC) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of COVID-19 >3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of COVID-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| convalescent participants PFIZER | Experimental | Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine |
|
| Naive participants PFIZER | Experimental | Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine |
|
| convalescent participants MODERNA | Experimental | Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine |
|
| Naive participants MODERNA | Experimental | Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine |
|
| Boost only | Experimental | Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA vaccine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine Pfizer (3 doses) | Biological | A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-S neutralizing antibody titer | The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization | Days : 15, 90, 180 after each dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic of Anti-S antibody titer | The antibody titer against protein S will be evaluated by ELISA | Days : 15, 90, 180 after each dose of vaccine |
| Kinetic of Anti-N antibody titer | The antibody titer against protein N will be evaluated by ELISA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth BOTELHO-NEVERS, MD PhD | CHU de St Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCL - Hôpital Croix Rousse | Lyon | 69004 | France | |||
| CHU de Saint-Etienne |
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| COVID-19 vaccine Pfizer (2 doses) | Biological | A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring |
|
| COVID-19 mRNA Vaccine Moderna (3 doses) | Biological | A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring |
|
| COVID-19 mRNA Vaccine Moderna (2 doses) | Biological | A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring |
|
| COVID-19 mRNA Vaccine Moderna (1 dose) | Biological | A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring |
|
| Days : 15, 90, 180 after each dose of vaccine |
| Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva | Days : 15, 90, 180 after each dose of vaccine |
| Kinetic of SARS-CoV-2 quantiferon value | Days : 15, 90, 180 after each dose of vaccine |
| CD4 and CD8 lymphocyte polarization specific to the vaccine S protein | Evaluate by TruCulture (Myriad) methode | Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine |
| Anti-S neutralizing antibody titer | The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization | Days : 15, 90, 180 after each dose of vaccine |
| Kinetic of serum cytokine levels | At 24 and 72 hours after each dose of vaccine |
| Kinetic of C-reactive protein | At 24 and 72 hours after each dose of vaccine |
| Kinetic of vaccine-induced genes signatures | Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells | At 24 and 72 hours after each dose of vaccine |
| Saint-Etienne |
| 42055 |
| France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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