Actively Recruiting
Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-04-25
215
Participants Needed
2
Research Sites
66 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
V
Vaccine Research Institute (VRI), France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to less than 85 years
- Able to understand and comply with study procedures and sign informed consent
- Received a primary COVID-19 mRNA vaccination series and at least one booster with last booster at least 6 months before study
- Adequate organ function with normal ALT, AST, and alkaline phosphatase
- Normal hematology lab values
- Negative virology assessment
- Normal urine test
- Meet eligibility criteria in the approved package labeling of the active comparator
- For women of childbearing potential: use effective contraception and negative pregnancy test
- For male participants: use effective contraception with partner
You will not qualify if you...
- Acute febrile infection within previous 72 hours or symptoms suggestive of COVID-19 or SARS-CoV-2 infection within past 28 days
- Use of immunosuppressive medications within 3 months or chemotherapy within 6 months before first vaccine dose
- Received immunoglobulins within 90 days before first vaccine dose
- Received blood products within 120 days before first vaccine dose
- Any medical condition impairing immune response such as cancer
- Use of any experimental therapy
- Participation in another investigational study within 4 weeks before enrollment or until study end
- Currently pregnant or breastfeeding
- History of severe adverse events after vaccine administration
- Bleeding disorders contraindicating intramuscular injection
- Conditions requiring active medical intervention or monitoring except mild, well-controlled asthma
- Hypertension
- BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of: age > 45, current smoker, known hyperlipidemia, high blood pressure (≥140/90 mm Hg)
- Malignancy
- Asplenia
- Seizure disorder
- History of hereditary, acquired, or idiopathic angioedema
- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent effects, or significant arrhythmia
- History of autoimmune disease
- Any condition interfering with protocol adherence as judged by investigator
- Psychiatric condition preventing protocol compliance
- Live attenuated vaccines received within 30 days before or scheduled within 28 days after last injection
- Non-live vaccines received within 21 days before first vaccine dose
- Allergy treatment with antigen injections within 30 days before first vaccine dose and until study end
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hopital Henri Mondor
Créteil, France, 94000
Actively Recruiting
2
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
Research Team
Y
Yves Levy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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