MedTrace Logo

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

NCT06255626 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-04-25

No results posted yet for this study

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

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))

Sponsors & Collaborators

  • Vaccine Research Institute (VRI), France

    collaborator UNKNOWN

  • EnnoDc (previously known as LinKinVax)

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06255626 on ClinicalTrials.gov