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Now that the COVID period has passed, patient recruitment has fallen off.
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Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against a (new) infection. This study aims to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and to assess the durability of this power in the time.
Infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against (new) infection. The purpose of this study is to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) depending on the treatments and/or vaccines received and to assess the durability of this power over time.
The main objective is to measure and describe the evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies).
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with collection of biological samples | Other | All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of biological samples | Other | All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 0 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 0 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 3 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 3 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 15 |
| Evolution of the serum humoral response |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 0 |
| Evolution of the mucosal humoral response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry PRAZUCK, Dr | CHR d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional d'Orléans, France | Orléans | 45000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32817357 | Background | Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17. | |
| 33772244 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Collection of biological samples (Day 0, D3, D15, Month 1, M2, M3, M4, M5, M6, M9, M12, M18) with associated data for the study of the kinetics of antibodies against COVID-19. All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.
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Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)
| Day 15 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 1 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 1 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 2 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 2 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 3 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 3 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 4 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 4 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 5 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 5 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 6 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 6 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 9 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 9 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 12 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 12 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 18 |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 18 |
Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) |
| Day 0 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 3 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 3 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 15 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 15 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 1 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 1 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 2 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 2 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 3 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 3 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 4 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 4 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 5 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 5 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 6 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 6 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 9 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 9 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 12 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 12 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 18 |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 18 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 0 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 3 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 15 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 1 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 2 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 3 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 4 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 5 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 6 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 9 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 12 |
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 18 |
| Background |
| Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26. |
| 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |