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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
COVID-19 vaccine Pfizer (2 doses)
COVID-19 vaccine Pfizer (1 dose)
COVID-19 mRNA Vaccine Moderna (2 doses)
COVID-19 mRNA Vaccine Moderna (1 dose)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Immunogenicity, reactogenicity, mRNA COVID-19 vaccine, COVID-19 natural immunity, age

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

  • Immunocompromised or under immunosuppressive treatment
  • Subject with a history of COVID hospitalized in intensive care
  • Subject allergic to one of the components of the vaccines used in the study
  • subject vaccinated for COVID-19
  • Subject with persistent symptoms of COVID-19 (long COVID)
  • Subjects with unstable chronic pathology
  • Persons deprived of liberty, hospitalized without consent
  • Pregnant or breastfeeding woman

Sites / Locations

  • HCL - Hôpital Croix Rousse
  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

convalescent participants PFIZER

Naive participants PFIZER

convalescent participants MODERNA

Naive participants MODERNA

Arm Description

Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine

Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine

Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine

Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine

Outcomes

Primary Outcome Measures

Anti-S neutralizing antibody titer
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
The antibody titer against protein S will be evaluated by ELISA
Kinetic of Anti-N antibody titer
The antibody titer against protein N will be evaluated by ELISA
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
Kinetic of SARS-CoV-2 quantiferon value
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein
Evaluate by TruCulture (Myriad) methode
Anti-S neutralizing antibody titer
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
Kinetic of C-reactive protein
Kinetic of vaccine-induced genes signatures
Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells

Full Information

First Posted
September 14, 2021
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Sanofi Pasteur, a Sanofi Company, Bioster, a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT05047718
Brief Title
Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19
Acronym
COVIMMUNAGE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Sanofi Pasteur, a Sanofi Company, Bioster, a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Immunogenicity, reactogenicity, mRNA COVID-19 vaccine, COVID-19 natural immunity, age

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
convalescent participants PFIZER
Arm Type
Experimental
Arm Description
Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine
Arm Title
Naive participants PFIZER
Arm Type
Experimental
Arm Description
Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine
Arm Title
convalescent participants MODERNA
Arm Type
Experimental
Arm Description
Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine
Arm Title
Naive participants MODERNA
Arm Type
Experimental
Arm Description
Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine
Intervention Type
Biological
Intervention Name(s)
COVID-19 vaccine Pfizer (2 doses)
Intervention Description
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Intervention Type
Biological
Intervention Name(s)
COVID-19 vaccine Pfizer (1 dose)
Intervention Description
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Intervention Type
Biological
Intervention Name(s)
COVID-19 mRNA Vaccine Moderna (2 doses)
Intervention Description
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Intervention Type
Biological
Intervention Name(s)
COVID-19 mRNA Vaccine Moderna (1 dose)
Intervention Description
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Primary Outcome Measure Information:
Title
Anti-S neutralizing antibody titer
Description
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 15 days after the last dose of vaccine
Secondary Outcome Measure Information:
Title
Kinetic of Anti-S antibody titer
Description
The antibody titer against protein S will be evaluated by ELISA
Time Frame
At 15 days, 3, 6 and 12 months after the last dose of vaccine
Title
Kinetic of Anti-N antibody titer
Description
The antibody titer against protein N will be evaluated by ELISA
Time Frame
At 15 days, 3, 6 and 12 months after the last dose of vaccine
Title
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
Time Frame
At 15 days, 3, 6 and 12 months after the last dose of vaccine
Title
Kinetic of SARS-CoV-2 quantiferon value
Time Frame
At 15 days, 3, 6 and 12 months after the last dose of vaccine
Title
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein
Description
Evaluate by TruCulture (Myriad) methode
Time Frame
At 15 days after the last dose of vaccine
Title
Anti-S neutralizing antibody titer
Description
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 3, 6 and 12 months after the last dose of vaccine
Title
Kinetic of serum cytokine levels
Time Frame
At 24 and 72 hours after each dose of vaccine
Title
Kinetic of C-reactive protein
Time Frame
At 24 and 72 hours after each dose of vaccine
Title
Kinetic of vaccine-induced genes signatures
Description
Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells
Time Frame
At 24 and 72 hours after each dose of vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria: Immunocompromised or under immunosuppressive treatment Subject with a history of COVID hospitalized in intensive care Subject allergic to one of the components of the vaccines used in the study subject vaccinated for COVID-19 Subject with persistent symptoms of COVID-19 (long COVID) Subjects with unstable chronic pathology Persons deprived of liberty, hospitalized without consent Pregnant or breastfeeding woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth BOTELHO-NEVERS, MD PhD
Organizational Affiliation
CHU de St Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCL - Hôpital Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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