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

December 6, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • HCL - Hôpital Croix Rousse
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (2 doses)
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 (3 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 (2 doses)
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 (3 doses)
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
Experimental: Boost only
Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anti-S neutralizing antibody titer
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
Days : 15, 90, 180 after each dose of vaccine

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinetic of serum cytokine levels
Time Frame: At 24 and 72 hours after each dose of vaccine
At 24 and 72 hours after each dose of vaccine
Kinetic of C-reactive protein
Time Frame: At 24 and 72 hours after each dose of vaccine
At 24 and 72 hours after each dose of vaccine
Kinetic of vaccine-induced genes signatures
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
At 24 and 72 hours after each dose of vaccine
Anti-S neutralizing antibody titer
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
Days : 15, 90, 180 after each dose of vaccine
Kinetic of Anti-S antibody titer
Time Frame: Days : 15, 90, 180 after each dose of vaccine
The antibody titer against protein S will be evaluated by ELISA
Days : 15, 90, 180 after each dose of vaccine
Kinetic of Anti-N antibody titer
Time Frame: Days : 15, 90, 180 after each dose of vaccine
The antibody titer against protein N will be evaluated by ELISA
Days : 15, 90, 180 after each dose of vaccine
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
Time Frame: Days : 15, 90, 180 after each dose of vaccine
Days : 15, 90, 180 after each dose of vaccine
Kinetic of SARS-CoV-2 quantiferon value
Time Frame: Days : 15, 90, 180 after each dose of vaccine
Days : 15, 90, 180 after each dose of vaccine
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein
Time Frame: Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine
Evaluate by TruCulture (Myriad) methode
Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi Pasteur, a Sanofi Company
Bioster, a.s.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisabeth BOTELHO-NEVERS, MD PhD, CHU de St Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21CH134
  • 2021-003547-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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