Effect of a Vaccination Against COVID-19 on Monocyte Production of Oxygenated Derivatives. (VACTICOV2)

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

How Does Vaccination Against COVID-19 Affect Monocyte Production of Oxygenated Derivatives ?

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this pandemic period, vaccination against SARSCoV- 2 is an essential weapon. However, the immune memory induced by current vaccines remains ephemeral, requiring early booster shots. It is primordial to improve this vaccine memory.

Recently it has been demonstrated that monocytes from certain individuals hospitalized for SARSCoV-2 infection spontaneously overproduced oxygenated derivatives (ROS) capable of inducing DNA damage in neighboring cells and T cell apoptosis (Kundura et al., 2022). In agreement with these observations, up to 50% of peripheral blood mononuclear cells (PBMC) from these patients showed DNA damage and its intensity was correlated with the percentage of apoptotic CD8+ T cells and lymphopenia.

Upon entry into the target cell, SARS-CoV-2 induces the internalization of its receptor, the protease Angiotensin Converting Enzyme 2 (ACE2), which is able to degrade Angiotensin II (AngII). Consequently, the circulating level of AngII was observed to be increased in some COVID-19 patients. It was also found that AngII induced monocyte ROS production via its receptor Angiotensin receptor 1 (AT1), making monocytes capable of damaging the DNA of co-cultured cells. Moreover, the plasma level of AngII in patients correlates with the level of ROS production and the ability to damage DNA of their monocytes. The level of anti SARS-CoV-2 antibodies was shown to be inversely correlated with the level of monocyte production of ROS production during the acute phase. This suggests that the activation cascade leading to lymphopenia described could damage the specific immune memory.

Now, a recent article has established the presence of circulating S1 vaccine antigen following the injection of an anti-SARS-CoV-2 vaccine with mRNA vaccine from D1 to D7 at a level of 68 ± 21 pg/mL (Ogata et al. 2022) similar to the level described in COVID-19 (Ogata et al. 2020). If the cascade of events we have identified is triggered by the circulation of the vaccine antigen, this could lead to could result in a reduced vaccine memory via lymphocyte apoptosis.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Nîmes, France, France, 30029
        • CHU de Nîmes, Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients under treatment with N-acetylcysteine or sartan.
  • Patients with a dysimmune pathology or immunosuppressive treatment.
  • Person infected with SARS-CoV-2 within 3 months prior to inclusion.
  • Person participating in a category 1 defined RIPH.
  • Subject in an exclusion period as determined by another study.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients vaccinated with the anti-SARS-Cov-2 vaccination
These patients will receive the anti-SARS-Cov-2 vaccination and their blood will be regularly monitored.
Biological: anti-SARS-Cov-2 vaccination
For the purposes of the study, 10 mL of venous blood will be collected from each patient.
Other Names:
  • Blood test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Time Frame: Day 0

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.
Time Frame: Day 7

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.
Time Frame: Day 14

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.
Time Frame: Day 28

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.
Time Frame: Day 0

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.
Time Frame: Day 7

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.
Time Frame: Day 14

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.
Time Frame: Day 28

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.
Time Frame: Day 0

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.
Time Frame: Day 7

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.
Time Frame: Day 14

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.
Time Frame: Day 28

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time Frame: Day 0
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 0
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 0
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 0
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time Frame: Day 0
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 0
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time Frame: Day 7
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 7
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time Frame: Day 7
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time Frame: Day 14
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 14
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time Frame: Day 14
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time Frame: Day 28
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 28
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 28
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 28
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time Frame: Day 28
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Day 28
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) before anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 0
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 0
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) before anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 0
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 0
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) before anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 0
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 0
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 7
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 7
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 7
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 7
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 7
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Day 7
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 14
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 14
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 14
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 14
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 14
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 14
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 28
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 28
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 28
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 28
B) DNA lesion rate (%) and intensity in peripheral blood mononuclear cells (PBMC) 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 28
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Day 28
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 0
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 0
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 0
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 0
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 7
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 7
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 7
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 7
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 7
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 7
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 14
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 14
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 14
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 14
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 14
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 14
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time Frame: Day 28
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 28
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time Frame: Day 28
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 28
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time Frame: Day 28
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Day 28
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Time Frame: Day 0
Complete blood count. Lymphocytes will be measured as a percentage.
Day 0
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 0
Complete blood count. Lymphocytes will be measured as a percentage.
Day 0
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Time Frame: Day 0
Complete blood count. Lymphocytes will be measured as a percentage.
Day 0
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Time Frame: Day 7
Complete blood count. Lymphocytes will be measured as a percentage.
Day 7
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 7
Complete blood count. Lymphocytes will be measured as a percentage.
Day 7
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Time Frame: Day 7
Complete blood count. Lymphocytes will be measured as a percentage.
Day 7
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Time Frame: Day 14
Complete blood count. Lymphocytes will be measured as a percentage.
Day 14
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 14
Complete blood count. Lymphocytes will be measured as a percentage.
Day 14
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Time Frame: Day 14
Complete blood count. Lymphocytes will be measured as a percentage.
Day 14
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Time Frame: Day 28
Complete blood count. Lymphocytes will be measured as a percentage.
Day 28
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Time Frame: Day 28
Complete blood count. Lymphocytes will be measured as a percentage.
Day 28
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Time Frame: Day 28
Complete blood count. Lymphocytes will be measured as a percentage.
Day 28
E) Quantification of anti-S antibodies in patients aged under 30 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Time Frame: Day 0
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Day 0
E) Quantification of anti-S antibodies in patients aged 30 - 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Time Frame: Day 28
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Day 28
E) Quantification of anti-S antibodies in patients aged over 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Time Frame: Day 28
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Day 28
F) Constitution of a biobank
Time Frame: Day 28
Plasma and cell samples will be referenced and stored for use in future studies.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO 2022-1
  • 2022-A02026-37 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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