Clinical trial

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

Name
NIMAO 2022-1
Description
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).
Trial arms
Trial start
2022-12-21
Estimated PCD
2023-06-20
Trial end
2024-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
anti-SARS-Cov-2 vaccination
For the purposes of the study, 10 mL of venous blood will be collected from each patient.
Arms:
Patients vaccinated with the anti-SARS-Cov-2 vaccination
Other names:
Blood test
Size
30
Primary endpoint
Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old before anti-SARS-CoV-2 vaccination with an mRNA vaccine.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Day 28
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot observational, single-center study with prospective longitudinal follow-up.\n\nType of study: Non-Health Product. Category according to the Jarde law : Interventional research involving human subjects with minimal risks and constraints, Category 2.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-06-05

1 organization

1 product

1 indication

Indication
COVID-19