volunteers MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: COVID-19 Vaccine Janssen
Pharmaceutical Form: Injection
Sponsors
CHU SAINT-ETIENNE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years old: >65 years old or 55 to 65 years old, or 18 to 45 years old, depending on the group of inclusion. - 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. - Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent. - Able to comply with study procedures based on Investigator judgement. - Affiliated to a social security system, (except state medical aid) 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Subject is ill or febrile (body temperature = 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit - History of documented COVID-19 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV- 2+) prior to the vaccine administration - Subjects with positive serology to SARS-CoV-2 at the enrolment visit. - Subjects who already received another anti-SARS-CoV-2-vaccine - Subjects who received BCG given within the last year. - An immediate family member or household member of study staff. - Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies - Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion. - Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection. - History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2- vaccine. - History of severe allergic event - Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visits or planned before the study completion. - Known HIV, active HCV or HBV infection - Any pathological condition, such as cancer, which may be susceptible of reducing immunity response - History of heparin-induced thrombocytopenia (HIT) - Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy - The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study - Any condition which in the opinion of the investigator may interfere with the aim of the study - Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit. - Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment - People 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 vaccine viral vector Janssen 28 days after single dose in volunteers aged: -more than 65 years -55 to 65 years -18 to 45 years ;Secondary Objective: 1.To assess humoral immune response after single dose vaccine and its maintenance or decay until M24 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-vaccinal immune response between young and old groups and more generally to assess the effect of age on markers of immune response. 6. To evaluate clinical safety 7.To collect occurrence of COVID-19 8.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) ;Timepoint(s) of evaluation of this end point: at day 29, (28 days after singe dose vaccine) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at Day 1, D29, D57, M6, M12 and M24;Secondary end point(s): 1. Anti SARS-CoV -2 specific IgG and IgM (total and subclasses IgG 1-4) Anti-SARS-CoV-2 -specific neutralizing antibody 2. Fluorospot assays (TH1, TH2, TH17, Cytotoxicity) 3. Mucosal SARS-CoV-2 -specific antibody 4. Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response 5. Pre-existing serology for SARS-CoV-2 or other coronavirus, Immunosenescence profile, transcriptomic analysis, immune cell phenotype. 6. Immediate reactogenicity defined as any adverse reactions occurring within 30 minutes after injection Local and systemic reactogenicity measured by solicited adverse reactions up to day 7 after injection Unsolicited adverse events (AE) through 28 days after single dose vaccine. Any AEs of grade = 2, until D29, then of grade = 3 throughout the study period. Serious adverse events (SAEs) and Adverse events of special interest (AESI) throughout the entire study period. 7. Occurrence of confirmed COVID-19 cases during the study period. | — |
Countries
France
Contacts
Public ContactCarine LABRUYERE
CHU Saint-Etienne
Outcome results
None listed