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

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: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: COVID-19 vaccine Pfizer (1 dose); Biological: COVID-19 vaccine Pfizer (2 doses); Biological: COVID-19 mRNA Vaccine Moderna (1 dose); Biological: COVID-19 mRNA Vaccine Moderna (2 doses)

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: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • HCL - Hôpital Croix Rousse
  • Saint-Étienne, France, 42055
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 (1 dose); 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 (2 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 (1 dose); 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 (2 doses); 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

Outcome Measure	Measure Description	Time Frame
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	At 15 days after the last dose of vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetic of Anti-S antibody titer	The antibody titer against protein S will be evaluated by ELISA	At 15 days, 3, 6 and 12 months after the last dose of vaccine
Kinetic of Anti-N antibody titer	The antibody titer against protein N will be evaluated by ELISA	At 15 days, 3, 6 and 12 months after the last dose of vaccine
Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva		At 15 days, 3, 6 and 12 months after the last dose of vaccine
Kinetic of SARS-CoV-2 quantiferon value		At 15 days, 3, 6 and 12 months after the last dose of vaccine
CD4 and CD8 lymphocyte polarization specific to the vaccine S protein	Evaluate by TruCulture (Myriad) methode	At 15 days after the 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	At 3, 6 and 12 months after the last dose of vaccine
Kinetic of serum cytokine levels		At 24 and 72 hours after each dose of vaccine
Kinetic of C-reactive protein		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	At 24 and 72 hours after each dose of vaccine

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Sanofi Pasteur, a Sanofi Company; Bioster, a.s.
• Investigators: Principal Investigator: Elisabeth BOTELHO-NEVERS, MD PhD, CHU de St Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: age; Immunogenicity; reactogenicity; mRNA COVID-19 vaccine; COVID-19 natural immunity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID 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