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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Covid19

Keywords

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Immunogenicity reactogenicity mRNA COVID-19 vaccine COVID-19 natural immunity age

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type BIOLOGICAL

A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth BOTELHO-NEVERS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de St Etienne

Locations

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HCL - Hôpital Croix Rousse

Lyon, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2021-003547-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21CH134

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

convalescent participants PFIZER

COVID-19 vaccine Pfizer (2 doses)

Naive participants PFIZER

COVID-19 vaccine Pfizer (3 doses)

convalescent participants MODERNA

COVID-19 mRNA Vaccine Moderna (2 doses)

Naive participants MODERNA

COVID-19 mRNA Vaccine Moderna (3 doses)

Boost only

COVID-19 mRNA Vaccine Moderna (1 dose)

Interventions