RecruitingPhase 1Phase 2NCT06255626

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

A Phase 1/2 Multicenter, Randomized Study of the Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.


Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

215 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CD40.RBDv vaccin (SARS-Cov2 Vaccin) for people with covid-19. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD40.RBDv vaccin (SARS-Cov2 Vaccin)

1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))


Locations(2)

Hopital Henri Mondor

Créteil, France

Hôpital Cochin

Paris, France

View Full Details on ClinicalTrials.gov

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NCT06255626


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