Covid19Phase 4COVIMMUNAGENCT05047718

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

A Phase 4 study testing COVID-19 vaccine Pfizer (3 doses), COVID-19 vaccine Pfizer (2 doses) and COVID-19 mRNA Vaccine Moderna (3 doses) in people with Covid19, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: COVID-19 vaccine Pfizer (3 doses), COVID-19 vaccine Pfizer (2 doses) and COVID-19 mRNA Vaccine Moderna (3 doses)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesFrance
Study dates: 5 Oct 2021to 28 Feb 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

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

Other trials in France

About this study

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

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.

Read the 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.

Conditions: Covid19
Being tested: COVID-19 vaccine Pfizer (3 doses), COVID-19 vaccine Pfizer (2 doses), COVID-19 mRNA Vaccine Moderna (3 doses), COVID-19 mRNA Vaccine Moderna (2 doses), COVID-19 mRNA Vaccine Moderna (1 dose)
Keywords: Immunogenicity, reactogenicity, mRNA COVID-19 vaccine, COVID-19 natural immunity, age
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-19 vaccine Pfizer (3 doses)Biological
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
COVID-19 vaccine Pfizer (2 doses)Biological
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
COVID-19 mRNA Vaccine Moderna (3 doses)Biological
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
COVID-19 mRNA Vaccine Moderna (2 doses)Biological
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
COVID-19 mRNA Vaccine Moderna (1 dose)Biological
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring

Study groups in NCT05047718
Study group	Role	What they receive
convalescent participants PFIZER	Experimental	Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine Receives: Biological: COVID-19 vaccine Pfizer (2 doses)
Naive participants PFIZER	Experimental	Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine Receives: Biological: COVID-19 vaccine Pfizer (3 doses)
convalescent participants MODERNA	Experimental	Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine Receives: Biological: COVID-19 mRNA Vaccine Moderna (2 doses)
Naive participants MODERNA	Experimental	Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine Receives: Biological: COVID-19 mRNA Vaccine Moderna (3 doses)
Boost only	Experimental	Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA vaccine. Receives: Biological: COVID-19 mRNA Vaccine Moderna (1 dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Days : 15, 90, 180 after each dose of vaccine

Secondary outcomes (9)

Kinetic of Anti-S antibody titer
The antibody titer against protein S will be evaluated by ELISA
Measured: Days : 15, 90, 180 after each dose of vaccine
Kinetic of Anti-N antibody titer
The antibody titer against protein N will be evaluated by ELISA
Measured: Days : 15, 90, 180 after each dose of vaccine
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
Measured: Days : 15, 90, 180 after each dose of vaccine
Kinetic of SARS-CoV-2 quantiferon value
Measured: Days : 15, 90, 180 after each dose of vaccine
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein
Evaluate by TruCulture (Myriad) methode
Measured: Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine
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
Measured: Days : 15, 90, 180 after each dose of vaccine
Kinetic of serum cytokine levels
Measured: At 24 and 72 hours after each dose of vaccine
Kinetic of C-reactive protein
Measured: At 24 and 72 hours after each dose of vaccine
Kinetic of vaccine-induced genes signatures
Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells
Measured: At 24 and 72 hours after each dose of vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202128 Feb 2023

First posted17 Sep 2021
Study start5 Oct 2021
Primary completion29 Aug 2022
Study completion28 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05047718
Sponsor's protocol ID: 21CH134
Other IDs: 2021-003547-24
Acronym: COVIMMUNAGE
Status last verified: Jun 2023
First submitted: 14 Sep 2021
Last updated: 11 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05047718
Acronym / sponsor ID: COVIMMUNAGE / 21CH134
Conditions: Covid19
Keywords: Immunogenicity, reactogenicity, mRNA COVID-19 vaccine, COVID-19 natural immunity, age
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Collaborators: Sanofi Pasteur, a Sanofi Company, Bioster, a.s.
Study start: 5 Oct 2021 (actual)
Primary completion: 29 Aug 2022 (actual)
Study completion: 28 Feb 2023 (actual)
First posted: 17 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
convalescent participants PFIZER	Experimental	Biological: COVID-19 vaccine Pfizer (2 doses)Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine
Naive participants PFIZER	Experimental	Biological: COVID-19 vaccine Pfizer (3 doses)Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine
convalescent participants MODERNA	Experimental	Biological: COVID-19 mRNA Vaccine Moderna (2 doses)Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine
Naive participants MODERNA	Experimental	Biological: COVID-19 mRNA Vaccine Moderna (3 doses)Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine
Boost only	Experimental	Biological: COVID-19 mRNA Vaccine Moderna (1 dose)Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA vaccine.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-19 vaccine Pfizer (3 doses)A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring	Biological	Naive participants PFIZER
COVID-19 vaccine Pfizer (2 doses)A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring	Biological	convalescent participants PFIZER
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	Biological	Naive participants MODERNA
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	Biological	convalescent participants MODERNA
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	Biological	Boost only

Primary outcome

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

9 secondary outcomes

Kinetic of Anti-S antibody titer
Time frame: 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
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
Time frame: 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
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
Anti-S neutralizing antibody titer
Time frame: Days : 15, 90, 180 after each dose of vaccine
Kinetic of serum cytokine levels
Time frame: 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
Kinetic of vaccine-induced genes signatures
Time frame: At 24 and 72 hours after each dose of vaccine

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elisabeth BOTELHO-NEVERS, MD PhD principal investigator

CHU de St Etienne

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-S neutralizing antibody titer (time frame: Days : 15, 90, 180 after each dose of vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.