Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut Pasteur | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The main objective of the study is to describe the temporal curve of COVID-19 IgG and neutralizing antibodies over 24 months in an identified population of patients who presented with SARS-CoV-2 virus infection. The secondary objectives are to characterize the kinetics of the antibodies according to the severity of the clinical presentation and patient's characteristics and to determine if the anti-SARS-CoV-2 antibodies retain their neutralizing capacity over time. A sub-study aims to describe the kinetic of neutralizing antibodies (in blood and nasal mucosa) after vaccination.
Given the seriousness of the global health consequences of the COVID-19 pandemic and the difficulty of covering the world population with effective vaccination, several questions arise:
MAIN EVALUATION
> Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at M24 at each of the sampling times (M0, M3, M6, M9, M12, M15, M18, M24)
SECONDARY EVALUATION CRITERIA
These information will be decisive in the event of successive waves of the SARS-CoV-2 epidemic given a low level of collective immunity (<10% in France at the end of 2020) in order to know whether previously affected patients are durably protected.
In the context of a lack of vaccine, results from this study would make it possible to select candidates for vaccination from the truly non-immune population.
Vaccine sub-study :
Study of the kinetic of neutralizing antibodies after vaccination :
Volunteers participants, provided they give a special agreement for the vaccine sub-study, will undergo an additional grid of samples to accurately study the kinetic of neutralizing antibodies before and monthly after (up to 6 months) receiving anti-SARS-CoV-2 vaccine (whatever the product used). A special attention will be given to the capacity of their antibodies to neutralize emerging variants. Samples will include blood and possibly nasopharyngeal swabs (not mandatory).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with biological samples | Experimental | Collection of biological samples (M0, M3, M6, M9, M12, M15, M18, M24) with associated data for the study of the kinetics of antibodies anti COVID-19 in subjects with documented SARS-CoV-2 infection (PCR and/or positive specific serology). In the vaccine sub-study: additional blood and nasopharyngeal samples before and after vaccination, up to 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling by venipuncture (and eventually by nasopharyngeal swab) | Other | Biological samples :
Associated data :
Blood Fractioning
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 0 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 3 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 6 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 9 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 12 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 15 |
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups | Month 12 |
| Presence of specific anti-SARS-CoV-2 antibodies in subgroups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thierry PRAZUCK, MD | CHU Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Orléans | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31992387 | Background | Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. | |
| 32113704 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Collection of biological samples (M0, M3, M6, M9, M12, M15, M18, M24) with associated data for the study of the kinetics of antibodies anti COVID-19 in subjects with documented SARS-CoV-2 infection (PCR and/or positive specific serology)
Not provided
Not provided
Not provided
Not provided
|
| Presence of specific anti-SARS-CoV-2 antibodies | Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time | Month 24 |
Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups
| Month 12 |
| Presence of specific anti-SARS-CoV-2 antibodies in subgroups | Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups | Month 24 |
| Neutralizing capacity of anti-SARS-CoV-2 antibodies | Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19 | Month 6 |
| Neutralizing capacity of anti-SARS-CoV-2 antibodies | Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19. | Month 12 |
| Neutralizing capacity of anti-SARS-CoV-2 antibodies | Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19. | Month 24 |
| Measurement of activated CD8 (CD38+DR+) in culture | Measurement of activated CD8 (CD38+DR+) in culture | Month 6 |
| Measurement of activated CD8 (CD38+DR+) in culture | Measurement of activated CD8 (CD38+DR+) in culture | Month 12 |
| Measurement of activated CD8 (CD38+DR+) in culture | Measurement of activated CD8 (CD38+DR+) in culture | Month 24 |
| Measurement of activated CD4 in culture | Measurement of activated CD4 in culture | Month 6 |
| Measurement of activated CD4 in culture | Measurement of activated CD4 in culture | Month 12 |
| Measurement of activated CD4 in culture | Measurement of activated CD4 in culture | Month 24 |
| Measurement of activated B lymphocytes in culture | Measurement of activated B lymphocytes in culture | Month 6 |
| Measurement of activated B lymphocytes in culture | Measurement of activated B lymphocytes in culture | Month 12 |
| Measurement of activated B lymphocytes in culture | Measurement of activated B lymphocytes in culture | Month 24 |
| Background |
| Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. |
| 32747185 | Background | Fafi-Kremer S, Bruel T, Madec Y, Grant R, Tondeur L, Grzelak L, Staropoli I, Anna F, Souque P, Fernandes-Pellerin S, Jolly N, Renaudat C, Ungeheuer MN, Schmidt-Mutter C, Collongues N, Bolle A, Velay A, Lefebvre N, Mielcarek M, Meyer N, Rey D, Charneau P, Hoen B, De Seze J, Schwartz O, Fontanet A. Serologic responses to SARS-CoV-2 infection among hospital staff with mild disease in eastern France. EBioMedicine. 2020 Sep;59:102915. doi: 10.1016/j.ebiom.2020.102915. Epub 2020 Jul 31. |
| 38088562 | Derived | Bolland W, Michel V, Planas D, Hubert M, Staropoli I, Guivel-Benhassine F, Porrot F, N'Debi M, Rodriguez C, Fourati S, Prot M, Planchais C, Hocqueloux L, Simon-Loriere E, Mouquet H, Prazuck T, Pawlotsky J-M, Bruel T, Schwartz O, Buchrieser J. High fusion and cytopathy of SARS-CoV-2 variant B.1.640.1. J Virol. 2024 Jan 23;98(1):e0135123. doi: 10.1128/jvi.01351-23. Epub 2023 Dec 13. |
| 37549192 | Derived | Clairon Q, Prague M, Planas D, Bruel T, Hocqueloux L, Prazuck T, Schwartz O, Thiebaut R, Guedj J. Modeling the kinetics of the neutralizing antibody response against SARS-CoV-2 variants after several administrations of Bnt162b2. PLoS Comput Biol. 2023 Aug 7;19(8):e1011282. doi: 10.1371/journal.pcbi.1011282. eCollection 2023 Aug. |
| 35891471 | Derived | Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |