The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine.
The main questions that will be studied are :
* Is the CD40.RBDv (adjuvanted or not) safe ? * Does the CD40.RBDv (adjuvanted or not) imply an immunologic response ? Participants will receive, depending on their randomization arm, 1 or 2 injections of the CD40.RBDv vaccine or a single injection of approved mRNA vaccine
Healthy volunteers Age ≥18 and <85
Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures
Who has received a primary series of vaccination and ≥ 1 booster(s) of COVID-19 mRNA vaccination(s) with the last boost at least 6 months prior to the inclusion in the study
Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline phosphatase
Acute febrile infection within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days
Immunosuppressive medications received within last three months before first IMP administration or within 6 months for chemotherapies
Immunoglobulins within 90 days before first IMP administration
Blood products within 120 days before first IMP administration
Parallel
CD40.RBDv vaccin (SARS-Cov2 Vaccin)
Drug1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))
Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration
These proportions of participants will be described with its 95% two-sided confidence interval.
Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1
The primary immunogenecity endpoint is the neutralization antibodies titers (anti -RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1 after each dose The geometric mean titers (GMTs) with 95% confidence intervals (CIs) will be calculated at baseline and at Month 1 after each dose.
Number of volunteers with solicited local and systemic Adverse Reactions (ARs)
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Number of volunteers with Adverse Events (AEs) other than solicited adverse events
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Number of volunteers with Serious Adverse Events (SAEs), grade 3 and grade 4
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Number of volunteers with events leading to discontinuation of the vaccine regimen
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen. Separate summaries will be produced for the following categories: * Serious adverse events * Adverse events that are possibly or probably related to vaccine * Adverse event leading to withdrawal from the study * After any vaccination and by vaccination
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ANRS, Emerging Infectious Diseases
Lead sponsor
Vaccine Research Institute (VRI), France
Collaborator
EnnoDc (previously known as LinKinVax)
Collaborator
