COVID-19PNASNCT05315583
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
A study testing Collection of biological samples in people with COVID-19 and SARS CoV 2 Infection, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection
- What is being tested?
- Collection of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
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.
Read the 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.
- Conditions
- COVID-19, SARS CoV 2 Infection
- Being tested
- Collection of biological samples
- Keywords
- COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 18
Secondary outcomes (36)
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)
Measured: 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-Fuse in ED50 (Effective Dilution 50% titers)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Dec 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Why it stopped: Now that the COVID period has passed, patient recruitment has fallen off.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PRAZUCK, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315583
- Sponsor's protocol ID
- CHRO-2022-03
- Acronym
- PNAS
- Status last verified
- Nov 2024
- First submitted
- 16 Mar 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32817357Planas 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.
PubMed 33772244Clairon 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.
PubMed 37549192
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
- ClinicalTrials.gov ID
- NCT05315583
- Acronym / sponsor ID
- PNAS / CHRO-2022-03
- Conditions
- COVID-19, SARS CoV 2 Infection
- Keywords
- COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Now that the COVID period has passed, patient recruitment has fallen off.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group with collection of biological samples | Other | Other: Collection of biological samplesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Minors
- Pregnant women
- Persons under tutorship or curatorship
- Protected adults
- Person under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological samplesAll 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 | Group with collection of biological samples |
Primary outcome
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
Evolution of the serum humoral response
Time frame: 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)
36 secondary outcomes
Evolution of the mucosal humoral response
Time frame: Day 0
Evolution of the mucosal humoral response
Time frame: Day 0
Evolution of the mucosal humoral response
Time frame: Day 3
Evolution of the mucosal humoral response
Time frame: Day 3
Evolution of the mucosal humoral response
Time frame: Day 15
Evolution of the mucosal humoral response
Time frame: Day 15
Evolution of the mucosal humoral response
Time frame: Month 1
Evolution of the mucosal humoral response
Time frame: Month 1
Evolution of the mucosal humoral response
Time frame: Month 2
Evolution of the mucosal humoral response
Time frame: Month 2
Evolution of the mucosal humoral response
Time frame: Month 3
Evolution of the mucosal humoral response
Time frame: Month 3
Evolution of the mucosal humoral response
Time frame: Month 4
Evolution of the mucosal humoral response
Time frame: Month 4
Evolution of the mucosal humoral response
Time frame: Month 5
Evolution of the mucosal humoral response
Time frame: Month 5
Evolution of the mucosal humoral response
Time frame: Month 6
Evolution of the mucosal humoral response
Time frame: Month 6
Evolution of the mucosal humoral response
Time frame: Month 9
Evolution of the mucosal humoral response
Time frame: Month 9
Evolution of the mucosal humoral response
Time frame: Month 12
Evolution of the mucosal humoral response
Time frame: Month 12
Evolution of the mucosal humoral response
Time frame: Month 18
Evolution of the mucosal humoral response
Time frame: Month 18
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Day 0
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Day 3
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Day 15
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 1
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 2
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 3
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 4
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 5
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 6
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 9
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 12
Proportion of participants developing COVID-19 infection after these treatments
Time frame: Month 18
Results and safety
The study was stopped early (reason given: Now that the COVID period has passed, patient recruitment has fallen off.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 32817357Grzelak 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.
- Background: PubMed 33772244Planas 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.
- Derived from this study: PubMed 37549192Clairon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PRAZUCK, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of biological samples in people with COVID-19 and SARS CoV 2 Infection, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Now that the COVID period has passed, patient recruitment has fallen off.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the serum humoral response (time frame: Day 0). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.