CORONAVIRUS INFECTIONSEarly Phase 1VACTICOV2NCT05655351
Effect of a Vaccination Against COVID-19 on Monocyte Production of Oxygenated Derivatives.
A Early Phase 1 study testing anti-SARS-Cov-2 vaccination in people with CORONAVIRUS INFECTIONS, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CORONAVIRUS INFECTIONS
- What is being tested?
- anti-SARS-Cov-2 vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2022to 30 Jul 2024
- Phase
- Early Phase 1
- 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
- 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.
Who cannot join
- 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.
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- Subject who is unable to give consent.
- Subject for whom it is impossible to give clear information.
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- CORONAVIRUS INFECTIONS
- Being tested
- anti-SARS-Cov-2 vaccination
- Keywords
- COVID-19, Coronavirus, Anti-SARS-CoV-2 Vaccine, Reactive Oxygen Species
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-SARS-Cov-2 vaccinationBiological
Also called Blood test
For the purposes of the study, 10 mL of venous blood will be collected from each patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: anti-SARS-Cov-2 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 28
Secondary outcomes (52)
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 0
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 0
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 0
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 7
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 14
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 28
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: Day 28
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
The AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine will be measured by ELISA assay.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage.
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: 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
Immunofluorescence measurement of the amount of γ-H2AX foci in PBMC as a percentage in patients aged under 30
Measured: Day 28
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 0
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 7
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 7
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 7
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 14
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 14
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 14
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 28
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 28
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
The percentage of T cells positive for annexin V (labelled with fluorescent annexin V) will be measured by flow cytometry
Measured: Day 28
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 0
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 0
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 0
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 7
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 7
D) Presence of lymphopenia 7 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 7
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 14
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 14
D) Presence of lymphopenia 14 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 14
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 28
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged 30 - 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 28
D) Presence of lymphopenia 28 days after anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Complete blood count. Lymphocytes will be measured as a percentage.
Measured: Day 28
E) Quantification of anti-S antibodies in patients aged under 30 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Measured: Day 0
E) Quantification of anti-S antibodies in patients aged 30 - 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Measured: Day 28
E) Quantification of anti-S antibodies in patients aged over 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
Anti-S antibodies will be quantified by enzyme-linked immunosorbent assay (ELISA) in Antibody Units/mL
Measured: Day 28
F) Constitution of a biobank
Plasma and cell samples will be referenced and stored for use in future studies.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start21 Dec 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CORONAVIRUS INFECTIONSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655351
- Sponsor's protocol ID
- NIMAO 2022-1
- Other IDs
- 2022-A02026-37
- Acronym
- VACTICOV2
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39800264
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Vaccination Against COVID-19 Affect Monocyte Production of Oxygenated Derivatives ?
- ClinicalTrials.gov ID
- NCT05655351
- Acronym / sponsor ID
- VACTICOV2 / NIMAO 2022-1
- Conditions
- CORONAVIRUS INFECTIONS
- Keywords
- COVID-19, Coronavirus, Anti-SARS-CoV-2 Vaccine, Reactive Oxygen Species
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 Dec 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.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients vaccinated with the anti-SARS-Cov-2 vaccination | Experimental | Biological: anti-SARS-Cov-2 vaccinationThese patients will receive the anti-SARS-Cov-2 vaccination and their blood will be regularly monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| anti-SARS-Cov-2 vaccinationAlso: Blood testFor the purposes of the study, 10 mL of venous blood will be collected from each patient. | Biological | Patients vaccinated with the anti-SARS-Cov-2 vaccination |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
52 secondary outcomes
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time frame: 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
A) Plasma AngII level before anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time frame: 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
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time frame: 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
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged under 30
Time frame: 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
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged over 60
Time frame: 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
A) Plasma AngII level after anti-SARS-CoV-2 vaccination with an mRNA vaccine in patients aged 30 - 60
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time frame: Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time frame: Day 0
C) Rate of T cell apoptosis before anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time frame: 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
C) Rate of T cell apoptosis 7 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time frame: 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
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged under 30
Time frame: 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
C) Rate of T cell apoptosis 14 days after anti-SARS-CoV-2 mRNA vaccination in patients aged over 60
Time frame: 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
C) Rate of T cell apoptosis 28 days after anti-SARS-CoV-2 mRNA vaccination in patients aged 30 - 60
Time frame: 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
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged under 30
Time frame: 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
D) Presence of lymphopenia before anti-SARS-CoV-2 vaccination by an mRNA vaccine in patients aged over 60
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 39800264Gimenez 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-SARS-Cov-2 vaccination in people with CORONAVIRUS INFECTIONS, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 4 Dec 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 12 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 NCT05655351, which also lists 1 linked publication.
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 4 Dec 2025.