COVIMMUNAGE: Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05047718

Collaborator

Sanofi Pasteur, a Sanofi Company (Industry), Bioaster (Other)

200

Enrollment

Locations

Arms

16.9

Anticipated Duration (Months)

66.7

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: COVID-19 vaccine Pfizer (2 doses) Biological: COVID-19 vaccine Pfizer (1 dose) Biological: COVID-19 mRNA Vaccine Moderna (2 doses) Biological: COVID-19 mRNA Vaccine Moderna (1 dose)	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Mar 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: convalescent participants PFIZER Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine	Biological: COVID-19 vaccine Pfizer (1 dose) A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Experimental: Naive participants PFIZER Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine	Biological: COVID-19 vaccine Pfizer (2 doses) A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Experimental: convalescent participants MODERNA Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine	Biological: COVID-19 mRNA Vaccine Moderna (1 dose) A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Experimental: Naive participants MODERNA Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine	Biological: COVID-19 mRNA Vaccine Moderna (2 doses) A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring

Outcome Measures

Primary Outcome Measures

Anti-S neutralizing antibody titer [At 15 days after the last 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

Secondary Outcome Measures

Kinetic of Anti-S antibody titer [At 15 days, 3, 6 and 12 months after the last dose of vaccine]
The antibody titer against protein S will be evaluated by ELISA
Kinetic of Anti-N antibody titer [At 15 days, 3, 6 and 12 months after the last dose of vaccine]
The antibody titer against protein N will be evaluated by ELISA
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva [At 15 days, 3, 6 and 12 months after the last dose of vaccine]
Kinetic of SARS-CoV-2 quantiferon value [At 15 days, 3, 6 and 12 months after the last dose of vaccine]
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein [At 15 days after the last dose of vaccine]
Evaluate by TruCulture (Myriad) methode
Anti-S neutralizing antibody titer [At 3, 6 and 12 months after the last 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
Kinetic of serum cytokine levels [At 24 and 72 hours after each dose of vaccine]
Kinetic of C-reactive protein [At 24 and 72 hours after each dose of vaccine]
Kinetic of vaccine-induced genes signatures [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For the group with a past history of COVID-19 (convalescents)= subject within ≥ 3 months after infection
For the NO past history of COVID-19 (naives), subject with no known history of COVID-19
Patient affiliated or entitled to a social security plan
Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator