COVID-19 vaccine Pfizer (3 doses)
BiologicalA longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
NCT Number: NCT05047718
Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
HCL - Hôpital Croix Rousse, Lyon, France
In addition, the reactogenicity following the vaccine, remains important with COVID-19 vaccines, whether using an Messenger RiboNucleic Acid (mRNA) technique or an adenovirus vector technique. A better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. There are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of COVID-19 and the type of vaccine administered. A better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk COVID-19 population.
Thus, in partnership with Sanofi Pasteur and Bioaster, the Group On Mucosal Immunity And Pathogens (GIMAP) and Circulating Immune Complexes (CIC) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of COVID-19 >3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of COVID-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Time frame: Days : 15, 90, 180 after each dose of vaccine
The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization
Time frame: Days : 15, 90, 180 after each dose of vaccine
The antibody titer against protein S will be evaluated by ELISA
Time frame: Days : 15, 90, 180 after each dose of vaccine
The antibody titer against protein N will be evaluated by ELISA
Time frame: Days : 15, 90, 180 after each dose of vaccine
Time frame: Days : 15, 90, 180 after each dose of vaccine
Time frame: Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine
Evaluate by TruCulture (Myriad) methode
Time frame: Days : 15, 90, 180 after each dose of vaccine
The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization
Time frame: At 24 and 72 hours after each dose of vaccine
Time frame: At 24 and 72 hours after each dose of vaccine
Time frame: At 24 and 72 hours after each dose of vaccine
Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells
Centre Hospitalier Universitaire de Saint Etienne
Other
Factors Influencing the COVID-19 Vaccine Immune Response (Reactogenicity and Immunogenicity) According to Age and Presence or Not of a Past History of COVID-19
Acronym: COVIMMUNAGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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