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NCT06255626Not yet recruiting

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.
ANRS, Emerging Infectious DiseasesPhase 1/2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
COVID-19
Drug/Device/Intervention
CD40.RBDv vaccin (SARS-Cov2 Vaccin)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ANRS, Emerging Infectious Diseases
Timeline & enrollment
Phase
Phase 1/2
Start date
Feb 01, 2024
End date
Sep 01, 2025
Enrollment
240 participants
Primary outcome

Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration,Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1

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

ICD-10 classifications
COVID-19, virus identifiedCOVID-19, virus not identifiedCoronavirus infection, unspecified siteViral infection, unspecifiedRift Valley fever
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06255626
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06255626 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by ANRS, Emerging Infectious Diseases and is currently Not yet recruiting. The study focuses on COVID-19. Target enrollment is 240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.