In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs. The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk. Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age. We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster. A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules. The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France
In this trial of the Covicompare project, we will therefore evaluate the immune response after Janssen vaccine in subjects aged more than 65 years and 55 to 65 years without a prior COVID-19, following the same immunomonitoring analyses as for the other CoviCompare project trials.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
one dose (0.5mL) at D1 and one dose (0.5mL) at D57
Chu de Dijon
Dijon, France
Centre Hospitalier Regional Lille
Lille, France
APHM
Marseille, France
Centre Hospitalier Universitaire Nantes
Nantes, France
Hopital Bichat
Paris, France
Hopital Cochin
Paris, France
Centre Hospitalier Universitaire Rennes
Rennes, France
Chu de Rouen
Rouen, France
Centre Hospitalier de Saint-Etienne
Saint-Etienne, France
Centre Hospitalier Tours
Tours, France
IgG humoral response to vaccine
Anti SARS-CoV-2 Spike IgG as measured by ELISA
Time frame: Day 29
IgG humoral response to vaccine
Anti SARS-CoV-2 Spike IgG (total and subclasses IgG 1-4) as measured by ELISA
Time frame: Day 1, Day 29, Day 57, Month 6, Month 12, Month 24
IgA humoral response to vaccine
Anti SARS-CoV-2 Spike IgA as measured by Elisa
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
IgM humoral response to vaccine
Anti SARS-CoV-2 Spike IgM as measured by Elisa
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
neutralizing antibody humoral response to vaccine
Anti-SARS-CoV-2 neutralizing antibody (pseudo-neutralization test using lentiviral models expressing SARS-Cov-2 proteins)
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
T cells response to vaccine
Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of SARS-CoV-2 specific T cells by mass cytometry
Time frame: Day 1, Day 57, Month 6
Mucosal response to vaccine
Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
B cell response to vaccine
Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response
Time frame: Day 1, Day 57, Month 6
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