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Completed

NCT Number: NCT05047718

Factors Influencing the COVID-19 Vaccine Immune Response 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HCL - Hôpital Croix Rousse, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva

    Time frame: Days : 15, 90, 180 after each dose of vaccine

  4. Kinetic of SARS-CoV-2 quantiferon value

    Time frame: Days : 15, 90, 180 after each dose of vaccine

  5. 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

  6. 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

  7. Kinetic of serum cytokine levels

    Time frame: At 24 and 72 hours after each dose of vaccine

  8. Kinetic of C-reactive protein

    Time frame: At 24 and 72 hours after each dose of vaccine

  9. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Bioster, a.s.
  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study 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

Acronym: COVIMMUNAGE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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