Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.

ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-84
SponsorANRS, Emerging Infectious Diseases

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

215 Participants
are divided into 4 treatment groups

Sponsors and collaborators

ANRS, Emerging Infectious Diseases

Lead sponsor

Vaccine Research Institute (VRI), France

Collaborator

EnnoDc (previously known as LinKinVax)

Collaborator