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RECRUITING
NCT06255626
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

215

Start Date

2024-05-27

Completion Date

2025-09

Last Updated

2025-04-25

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

CD40.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