Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies

NCT05315583 | Terminated

• 1 other identifier: CHRO-2022-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS CoV 2 Infection

Keywords

COVID-19; Vaccines; Monoclonal antibodies; Neutralization; Serum; Nasal mucosa

Outcome Measures

Primary Outcomes (24)

• 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

  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

Secondary Outcomes (36)

• Evolution of the mucosal humoral response

  Day 0

• Evolution of the mucosal humoral response

  Day 0

• Evolution of the mucosal humoral response

  Day 3

• Evolution of the mucosal humoral response

  Day 3

• Evolution of the mucosal humoral response

  Day 15

Study Arms (1)

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.

Other: Collection of biological samples

Interventions

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.

Group with collection of biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult volunteers for the study, having received or about to receive any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies).
• Having given their consent to participate in the study

You may not qualify if:

• Minors
• Pregnant women
• Persons under tutorship or curatorship
• Protected adults
• Person under legal protection
• Person not affiliated to a social security scheme
• Persons unable to express their consent

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Régional d'Orléans, France

Orléans, 45000, France

Location

Related Publications (3)

• 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.

  PMID: 32817357 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.

  PMID: 33772244 BACKGROUND

• 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.

  PMID: 37549192 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thierry PRAZUCK, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 7, 2022
• Study Start: December 1, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

FR (1)