NCT06255626

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.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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

Detailed description

Phase 1/2a randomized, multicentre trial with four cohorts of two arms in two parts. Part 1: Cohort 1: Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) Cohort 2: LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) Cohort 3: High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) Cohort 4: SC injection of HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) A substancial amendment (January 2025) has removed the randomisation to mRNA vaccine from the study design Go-criterion for opening enrolment within cohorts are detailed into the protocol. Part 2 at Month 3 : Group 1: Volunteers who received mRNA vaccine in Part 1 will not receive any vaccine Group 2: Volunteers who received a first dose of CD40.RBDv vaccine (adjuvanted or not) in Part 1 but randomized (1:1) to receive no further dose of vaccine in Part 2. Group 3: Volunteers who received a first dose of CD40.RBDv vaccine (adjuvanted or not) in Part 1 and randomized (1:1) to receive an additional dose of CD40.RBDv vaccine (adjuvanted or not)

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	CD40.RBDv vaccin (SARS-Cov2 Vaccin)	1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-02-13
• Last updated: 2025-04-25

Locations

2 sites across 1 country: France