Healthy volunteers MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Comirnaty
Product Name: Comirnaty
Product Code: BNT162b2
Pharmaceutical Form: Dispersion for injection
Sponsors
Inserm-ANRS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 45 years old or at least 65 years old, 2. Healthy adults or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future. 3. Group 1: Healthy adults with no previous history of SARS CoV-2 infection (PCR-, antigenic test- or chest TDM- or serology SARS-CoV-2-) Group 2: Healthy adults with history of documented infection with SARS-CoV-2 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2+ of more than 6 months) 4. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: - Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. - OR Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to vaccination until at least 4 weeks after the last vaccination. A participant of childbearing potential must have a negative blood pregnancy test at enrolment visit. 5. Understands and agrees to comply with the study procedures (visits, phone calls) based on Investigator judgement 6. Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the trial) (article L1122-1-1 of the Public Health Code) 7. Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (AME is not a social security scheme) 8. A person who agrees to be registered in the national file of persons who lend themselves to biomedical research (article L1121-16 of the Public Health Code). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Subject is ill or febrile (body temperature = 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 or being contact subject within the past 14 days at enrolment visit. (Ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms, except if condition is COVID19) 2. Participants with positive serology SARS-CoV-2 at the enrolment visit (only for the group 1) 3. Participants who already received another anti-SARS-CoV-2-vaccine 4. Participants who received BCG within the last year. 5. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies 6. Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. 7. Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection. 8. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine. 9. History of severe allergic event 10. Known HIV, active HCV or HBV infection 11. Any pathological condition, such as cancer (i.e. for which the treatment was completed less than two years ago) or others which may be susceptible of reducing immunity response 12. Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy 13. The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study 14. Any condition which in the opinion of the investigator may interfere with the aim of the study 15. Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit. 16. An immediate family member or household member of study staff. 17. Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion. 18. Participant under legal protection measure (tutorship, curatorship or safeguard measures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the humoral immune response to the COVID-19 mRNA Vaccine BNT162b2 in adult volunteers with or without documented history of SARS CoV-2 infection, 28 days after the last injection.;Secondary Objective: 1. To characterize humoral immune response induced by BNT162b2 at D29 (group 1) and the immune response durability at M6, M12 and M24 for the 2 groups (with or without documented history of SARS CoV-2 infection) 2. To assess and characterize antigen-specific T cell response 3. To evaluate mucosal immunity 4. To determine the repertoire and polyclonality of humoral response 5. To compare the various post-vaccine immune response between young and old groups and more generally to assess the effect of age on markers of immune response 6. To identify biomarkers predicting of absence or non-persistence of humoral response 7. To evaluate clinical and biological safety 8. To collect occurrence of SARS CoV-2 infection 9. To biobank biological materials (plasma, serum, PBMC…) to address to other secondary ancillary projects ;Primary end point(s): Anti SARS-CoV-2 Spike IgG (ELISA test) 28 days after the last injection i.e. at D57 in adults volunteers receiving 2 vaccine doses (group 1, without documented history of SARS CoV-2 infection) and at D29 in adults volunteers receiving 1 vaccine dose (group 2, with documented history of SARS CoV-2 infection);Timepoint(s) of evaluation of this end point: D57 in adults volunteers receiving 2 vaccine doses D29 in adults volunteers receiving 1 vaccine dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anti SARS-CoV-2 specific IgG at Day 1, D29 (group1), D57 (group 2), M6, M12 and M24 as measured via ELISA Anti SARS-CoV-2 IgA and IgM (total and subclasses IgG 1-4) as measured by ELISA at D 1, D29, D57, M6, M12 and M24 Anti-SARS-CoV-2 -specific neutralizing antibody (classical in vitro neutralisation assay) at D 1, D29, D57, M6, M12, M24 (all participants) Anti-SARS-CoV-2-specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins) at D 1, D29, D57, M6, M12, M24 (all participants) 2. Fluorospot assays (TH1, TH2, TH17, Cytotoxicity) at D 1, D29 and M6 Phenotyping of antigen specific T-Cells via Mass cytometry at D 1 and M6 selected from results of Fluorospot assay These assessments will be performed only on 150 participants: 20 of each subgroup of group 1 and 10 of each subclass for group 2 for fluorospot and for cytometry analysis NB: Samples from following included people will be stored for biobanking 3. Mucosal SARS-CoV-2 -specific antibody via measure of IgA, IgM and IgG in saliva by specific home-made and commercially available ELISA assays for salivary IgA and IgG at D1, D29, D57, M6, M12 and M24 (all participants) 4. Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response at D1, D57 M12 These assessments will be performed only on 150 participants: 20 of each subgroup of group 1 and 10 of each subclass for group 2 NB: Samples from following included people will be stored for biobanking 5. Pre-existing serology for SARS-CoV-2 or other coronavirus, clinical profile of COVID 19 for group 2, immunosenescence profile, transcriptomic analysis, immune cell phenotype These assessments will be performed only on a subgroup of patients selected with different types of humoral response. 6. a. All grade adverse reactions: - Immediate reactogenicity defined as any adverse reactions occurring within 30 minutes after each injectio | — |
Countries
France
Contacts
Public ContactMaeva Lefebvre
CHU de Nantes
Outcome results
None listed