Clinical Trial

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

Recruiting Phase 1/2
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Record status
This record was last updated April 25, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-12; most recent amendment 2025-04-23.
Status change: Not Yet Recruiting → Recruiting 2024-06-11
Trial Details
NCT Number NCT06255626
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Vaccine Research Institute (VRI), France, EnnoDc (previously known as LinKinVax)
Conditions COVID-19
Enrollment 215 participants
Start Date 2024-05-27
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-25