Clinical trial NCT05315583: Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Official title: Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
SARS CoV 2 Infection
Keywords: COVID-19
Vaccines
Monoclonal antibodies
Neutralization
Serum
Nasal mucosa
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the serum humoral response
timeFrame: Day 0
measure: Evolution of the serum humoral response
timeFrame: Day 0
measure: Evolution of the serum humoral response
timeFrame: Day 3
measure: Evolution of the serum humoral response
timeFrame: Day 3
measure: Evolution of the serum humoral response
timeFrame: Day 15
measure: Evolution of the serum humoral response
timeFrame: Day 15
measure: Evolution of the serum humoral response
timeFrame: Month 1
measure: Evolution of the serum humoral response
timeFrame: Month 1
measure: Evolution of the serum humoral response
timeFrame: Month 2
measure: Evolution of the serum humoral response
timeFrame: Month 2
measure: Evolution of the serum humoral response
timeFrame: Month 3
measure: Evolution of the serum humoral response
timeFrame: Month 3
measure: Evolution of the serum humoral response
timeFrame: Month 4
measure: Evolution of the serum humoral response
timeFrame: Month 4
measure: Evolution of the serum humoral response
timeFrame: Month 5
measure: Evolution of the serum humoral response
timeFrame: Month 5
measure: Evolution of the serum humoral response
timeFrame: Month 6
measure: Evolution of the serum humoral response
timeFrame: Month 6
measure: Evolution of the serum humoral response
timeFrame: Month 9
measure: Evolution of the serum humoral response
timeFrame: Month 9
measure: Evolution of the serum humoral response
timeFrame: Month 12
measure: Evolution of the serum humoral response
timeFrame: Month 12
measure: Evolution of the serum humoral response
timeFrame: Month 18
measure: Evolution of the serum humoral response
timeFrame: Month 18
Secondary outcomes:
measure: Evolution of the mucosal humoral response
timeFrame: Day 0
measure: Evolution of the mucosal humoral response
timeFrame: Day 0
measure: Evolution of the mucosal humoral response
timeFrame: Day 3
measure: Evolution of the mucosal humoral response
timeFrame: Day 3
measure: Evolution of the mucosal humoral response
timeFrame: Day 15
measure: Evolution of the mucosal humoral response
timeFrame: Day 15
measure: Evolution of the mucosal humoral response
timeFrame: Month 1
measure: Evolution of the mucosal humoral response
timeFrame: Month 1
measure: Evolution of the mucosal humoral response
timeFrame: Month 2
measure: Evolution of the mucosal humoral response
timeFrame: Month 2
measure: Evolution of the mucosal humoral response
timeFrame: Month 3
measure: Evolution of the mucosal humoral response
timeFrame: Month 3
measure: Evolution of the mucosal humoral response
timeFrame: Month 4
measure: Evolution of the mucosal humoral response
timeFrame: Month 4
measure: Evolution of the mucosal humoral response
timeFrame: Month 5
measure: Evolution of the mucosal humoral response
timeFrame: Month 5
measure: Evolution of the mucosal humoral response
timeFrame: Month 6
measure: Evolution of the mucosal humoral response
timeFrame: Month 6
measure: Evolution of the mucosal humoral response
timeFrame: Month 9
measure: Evolution of the mucosal humoral response
timeFrame: Month 9
measure: Evolution of the mucosal humoral response
timeFrame: Month 12
measure: Evolution of the mucosal humoral response
timeFrame: Month 12
measure: Evolution of the mucosal humoral response
timeFrame: Month 18
measure: Evolution of the mucosal humoral response
timeFrame: Month 18
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Day 0
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Day 3
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Day 15
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 1
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 2
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 3
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 4
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 5
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 6
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 9
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 12
measure: Proportion of participants developing COVID-19 infection after these treatments
timeFrame: Month 18
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans, France
Study officials:
affiliation: CHR d'Orléans
name: Thierry PRAZUCK, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.