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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Biological: COVID-19 mRNA Vaccine Moderna (3 doses); Biological: COVID-19 mRNA Vaccine Moderna (2 doses); Biological: COVID-19 mRNA Vaccine Moderna (1 dose); Biological: COVID-19 vaccine Pfizer (3 doses); Biological: COVID-19 vaccine Pfizer (2 doses)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05047718

2021-003547-24 (EudraCT Number)

21CH134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 5 patient groups

convalescent participants PFIZER

Experimental group

Description:

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

Treatment:

Biological: COVID-19 vaccine Pfizer (2 doses)

Naive participants PFIZER

Experimental group

Description:

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

Treatment:

Biological: COVID-19 vaccine Pfizer (3 doses)

convalescent participants MODERNA

Experimental group

Description:

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

Treatment:

Biological: COVID-19 mRNA Vaccine Moderna (2 doses)

Naive participants MODERNA

Experimental group

Description:

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

Treatment:

Biological: COVID-19 mRNA Vaccine Moderna (3 doses)

Boost only

Experimental group

Description:

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

Treatment:

Biological: COVID-19 mRNA Vaccine Moderna (1 dose)