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

Covid19 Clinical Trial

— COVIMMUNAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047718
• Other study ID #: 21CH134
• Secondary ID: 2021-003547-24
• Status: Completed
• Phase: Phase 4
• Start date: October 5, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 28, 2023
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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
• COVID-19 vaccine Pfizer (1 dose)
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)
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)
A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring

Locations

Country	Name	City	State
France	HCL - Hôpital Croix Rousse	Lyon
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Bioster, a.s., Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Kinetic of SARS-CoV-2 quantiferon value		At 15 days, 3, 6 and 12 months after the last dose of vaccine
Secondary	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
Secondary	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
Secondary	Kinetic of serum cytokine levels		At 24 and 72 hours after each dose of vaccine
Secondary	Kinetic of C-reactive protein		At 24 and 72 hours after each dose of vaccine
Secondary	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