Clinical trial NCT05047718: Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: Immunogenicity
reactogenicity
mRNA COVID-19 vaccine
COVID-19 natural immunity
age
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
name: Bioster, a.s.
First posted: 2021-09-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anti-S neutralizing antibody titer
timeFrame: Days : 15, 90, 180 after each dose of vaccine
Secondary outcomes:
measure: Kinetic of Anti-S antibody titer
timeFrame: Days : 15, 90, 180 after each dose of vaccine
measure: Kinetic of Anti-N antibody titer
timeFrame: Days : 15, 90, 180 after each dose of vaccine
measure: Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva
timeFrame: Days : 15, 90, 180 after each dose of vaccine
measure: Kinetic of SARS-CoV-2 quantiferon value
timeFrame: Days : 15, 90, 180 after each dose of vaccine
measure: CD4 and CD8 lymphocyte polarization specific to the vaccine S protein
timeFrame: Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine
measure: Anti-S neutralizing antibody titer
timeFrame: Days : 15, 90, 180 after each dose of vaccine
measure: Kinetic of serum cytokine levels
timeFrame: At 24 and 72 hours after each dose of vaccine
measure: Kinetic of C-reactive protein
timeFrame: At 24 and 72 hours after each dose of vaccine
measure: Kinetic of vaccine-induced genes signatures
timeFrame: At 24 and 72 hours after each dose of vaccine
Other outcomes:
Locations:
city: Lyon
country: France
facility: HCL - Hôpital Croix Rousse
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de St Etienne
name: Elisabeth BOTELHO-NEVERS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: