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

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05315583
Collaborator
(none)
400
1
1
42
9.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of biological samples
N/A

Detailed Description

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:
  • to measure and describe the antibody response at the level of the nasal mucosa (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies, collected by means of a nasal swab) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies SARS-CoV-2.

  • to describe the incidence of COVID in the study patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Group with collection of biological samples

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
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.

Outcome Measures

Primary Outcome Measures

  1. Evolution of the serum humoral response [Day 0]

    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)

  2. Evolution of the serum humoral response [Day 0]

    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)

  3. Evolution of the serum humoral response [Day 3]

    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)

  4. Evolution of the serum humoral response [Day 3]

    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)

  5. Evolution of the serum humoral response [Day 15]

    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)

  6. Evolution of the serum humoral response [Day 15]

    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)

  7. Evolution of the serum humoral response [Month 1]

    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)

  8. Evolution of the serum humoral response [Month 1]

    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)

  9. Evolution of the serum humoral response [Month 2]

    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)

  10. Evolution of the serum humoral response [Month 2]

    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)

  11. Evolution of the serum humoral response [Month 3]

    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)

  12. Evolution of the serum humoral response [Month 3]

    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)

  13. Evolution of the serum humoral response [Month 4]

    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)

  14. Evolution of the serum humoral response [Month 4]

    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)

  15. Evolution of the serum humoral response [Month 5]

    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)

  16. Evolution of the serum humoral response [Month 5]

    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)

  17. Evolution of the serum humoral response [Month 6]

    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)

  18. Evolution of the serum humoral response [Month 6]

    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)

  19. Evolution of the serum humoral response [Month 9]

    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)

  20. Evolution of the serum humoral response [Month 9]

    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)

  21. Evolution of the serum humoral response [Month 12]

    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)

  22. Evolution of the serum humoral response [Month 12]

    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)

  23. Evolution of the serum humoral response [Month 18]

    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)

  24. Evolution of the serum humoral response [Month 18]

    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)

Secondary Outcome Measures

  1. Evolution of the mucosal humoral response [Day 0]

    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)

  2. Evolution of the mucosal humoral response [Day 0]

    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)

  3. Evolution of the mucosal humoral response [Day 3]

    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)

  4. Evolution of the mucosal humoral response [Day 3]

    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)

  5. Evolution of the mucosal humoral response [Day 15]

    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)

  6. Evolution of the mucosal humoral response [Day 15]

    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)

  7. Evolution of the mucosal humoral response [Month 1]

    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)

  8. Evolution of the mucosal humoral response [Month 1]

    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)

  9. Evolution of the mucosal humoral response [Month 2]

    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)

  10. Evolution of the mucosal humoral response [Month 2]

    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)

  11. Evolution of the mucosal humoral response [Month 3]

    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)

  12. Evolution of the mucosal humoral response [Month 3]

    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)

  13. Evolution of the mucosal humoral response [Month 4]

    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)

  14. Evolution of the mucosal humoral response [Month 4]

    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)

  15. Evolution of the mucosal humoral response [Month 5]

    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)

  16. Evolution of the mucosal humoral response [Month 5]

    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)

  17. Evolution of the mucosal humoral response [Month 6]

    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)

  18. Evolution of the mucosal humoral response [Month 6]

    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)

  19. Evolution of the mucosal humoral response [Month 9]

    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)

  20. Evolution of the mucosal humoral response [Month 9]

    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)

  21. Evolution of the mucosal humoral response [Month 12]

    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)

  22. Evolution of the mucosal humoral response [Month 12]

    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)

  23. Evolution of the mucosal humoral response [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-Flow in BAU/ml (Binding Antibody Unit/milliliter)

  24. Evolution of the mucosal humoral response [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)

  25. Proportion of participants developing COVID-19 infection after these treatments [Day 0]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  26. Proportion of participants developing COVID-19 infection after these treatments [Day 3]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  27. Proportion of participants developing COVID-19 infection after these treatments [Day 15]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  28. Proportion of participants developing COVID-19 infection after these treatments [Month 1]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  29. Proportion of participants developing COVID-19 infection after these treatments [Month 2]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  30. Proportion of participants developing COVID-19 infection after these treatments [Month 3]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  31. Proportion of participants developing COVID-19 infection after these treatments [Month 4]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  32. Proportion of participants developing COVID-19 infection after these treatments [Month 5]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  33. Proportion of participants developing COVID-19 infection after these treatments [Month 6]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  34. Proportion of participants developing COVID-19 infection after these treatments [Month 9]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  35. Proportion of participants developing COVID-19 infection after these treatments [Month 12]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

  36. Proportion of participants developing COVID-19 infection after these treatments [Month 18]

    Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Régional d'Orléans, France Orléans France 45000

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Thierry PRAZUCK, Dr, CHR d'Orléans

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT05315583
Other Study ID Numbers:
  • CHRO-2022-03
First Posted:
Apr 7, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022