Effect of a Vaccination Against COVID-19 on Monocyte Production of Oxygenated Derivatives.

NCT05655351 | Completed Early Phase 1

• 2 other identifiers: NIMAO 2022-12022-A02026-37
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Knowing that the vaccine antigen includes the ACE2 binding moiety (RBD), the hypothesis is that circulating vaccine antigen could reduce the enzymatic activity of ACE2, and thus increase circulating AngII concentration, monocyte ROS production and lymphocyte apoptosis. This hypothesis is supported by the fact that the Spike protein of SARSCoV-1, which uses the same receptor as SARS-CoV-2, induces a decrease in expression and activation of the Angiotensin II pathway in mice (Kuba et al. 2005).

Conditions

CORONAVIRUS INFECTIONS

Keywords

COVID-19; Coronavirus; Anti-SARS-CoV-2 Vaccine; Reactive Oxygen Species

Outcome Measures

Primary Outcomes (12)

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old before anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 0

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 7

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 14

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 28

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 0

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 7

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 14

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (ROS) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 28

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 0

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 7

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 14

• Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.

  The change (%) in the mean intensity of monocyte oxygen derivative (Reactive oxygen species) production will be measured by flow cytometry. All data will be collected on standardized electronic clinical report form available online. For ROS quantification: 106 PBMC will be re-suspended in 1μM dichloro-dihydro-fluorescein acetate (DCFH-DA) for 25minutes at room temperature. Data will be acquired on a Navios flow cytometer (Beckman Coulter) from 20,000 controlled events per sample and analyzed using Kaluza software (Kundura et al. 2022, in revision). The samples will be anonymized for blind measurement (at the Institute of Human Genetics in the team of Prof. Pierre Corbeau).

  Day 28

Secondary Outcomes (52)

• A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30

  Day 0

• A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60

  Day 0

• A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60

  Day 0

• A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30

  Day 7

• A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60

  Day 7

Study Arms (1)

Patients vaccinated with the anti-SARS-Cov-2 vaccination

EXPERIMENTAL

These patients will receive the anti-SARS-Cov-2 vaccination and their blood will be regularly monitored.

Biological: anti-SARS-Cov-2 vaccination

Interventions

anti-SARS-Cov-2 vaccination BIOLOGICAL

For the purposes of the study, 10 mL of venous blood will be collected from each patient.

Also known as: Blood test

Patients vaccinated with the anti-SARS-Cov-2 vaccination

Eligibility Criteria

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

You may qualify if:

• Candidate for SARS-CoV-2 vaccination with an mRNA vaccine (Pfizer, Moderna).
• Subject has given free and informed consent.
• Subject who has signed the consent form.
• Person affiliated to or beneficiary of a health insurance plan.

You may not qualify if:

• Patients under treatment with N-acetylcysteine or sartan.
• Patients with a dysimmune pathology or immunosuppressive treatment.
• Person participating in a category 1 defined RIPH.
• Person under court protection, guardianship or trusteeship.
• Subject who is unable to give consent.
• Subject for whom it is impossible to give clear information.
• Pregnant or breastfeeding woman.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes, Hôpital Universitaire Caremeau

Nîmes, France, 30029, France

Location

Related Publications (1)

• Gimenez S, Hamrouni E, Andre S, Picard M, Soundaramourty C, Lozano C, Vincent T, Tran TA, Kundura L, Estaquier J, Corbeau P. Monocytic reactive oxygen species-induced T-cell apoptosis impairs cellular immune response to SARS-CoV-2 mRNA vaccine. J Allergy Clin Immunol. 2025 May;155(5):1635-1646. doi: 10.1016/j.jaci.2025.01.003. Epub 2025 Jan 10.

  PMID: 39800264 RESULT

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot observational, single-center study with prospective longitudinal follow-up. Type of study: Non-Health Product. Category according to the Jarde law : Interventional research involving human subjects with minimal risks and constraints, Category 2.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 19, 2022
• Study Start: December 21, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 4, 2025

Record last verified: 2024-09

Locations

FR (1)