RecruitingCOVID-19

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

Eligible age

18–84 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

Yes

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About this study

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

Sponsor: ANRS, Emerging Infectious Diseases

You may qualify if…

✓ Healthy volunteers Age ≥18 and \<85
✓ Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures
✓ Who has received a primary series of vaccination and ≥ 1 booster(s) of COVID-19 mRNA vaccination(s) with the last boost at least 6 months prior to the inclusion in the study
✓ Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline phosphatase
✓ Normal haematology lab values
✓ Negative virology assessment
✓ Normal Urine testing
✓ Volunteers must meet the eligibility criteria in the approved package labelling of the active comparator

You may not qualify if…

✕ Acute febrile infection within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days
✕ Immunosuppressive medications received within last three months before first IMP administration or within 6 months for chemotherapies
✕ Immunoglobulins within 90 days before first IMP administration
✕ Blood products within 120 days before first IMP administration
✕ Any medical condition, such as cancer, that might impair the immune response
✕ Use of any experimental therapy
✕ Intent to participate in another study of an investigational research agent within 4 weeks prior to the enrolment visit or until the end of the study
✕ Currently pregnant or breastfeeding

Source: ClinicalTrials.gov · NCT06255626 · last updated 2025-04-25