About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CD40.RBDv vaccin (SARS-Cov2 Vaccin)
Treatment groups
Sponsors and collaborators
ANRS, Emerging Infectious Diseases
Lead sponsor
Vaccine Research Institute (VRI), France
Collaborator
EnnoDc (previously known as LinKinVax)
Collaborator