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

Recruiting now · Phase 1/Phase 2

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT06255626

Run by

ANRS, Emerging Infectious Diseases

People needed

215

Starts

2024-05-27

Expected to finish

2025-09-01

Last updated by the study team

2025-04-25

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: accepted.

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
• For women of childbearing potential: use of an effective contraceptive method and negative pregnancy test. For male participants, use of an effective method of contraception with their partner

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
• History of severe adverse events following vaccine administration
• Any bleeding disorder considered as a contraindication to an intramuscular injection
• A condition that requires active medical intervention or monitoring to avert grave danger to Asthma other than mild, well-controlled asthma.
• Hypertension
• BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of the following: age > 45, current smoker, known hyperlipidemia, blood pressure is defined as consistently ≥ 140 mm Hg systolic and ≥ 90 mm Hg diastolic
• Malignancy
• Asplenia
• Seizure disorder
• History of hereditary angioedema acquired angioedema, or idiopathic angioedema
• History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up
• History of autoimmune disease
• Any medical, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence
• Psychiatric condition that precludes compliance with the protocol.
• Live attenuated vaccines received within 30 days before first IMP administration or scheduled within 28 days after one of the last injection according to the protocol
• Vaccines that are not live attenuated vaccines and were received within 21 days prior to first IMP administration
• Allergy treatment with antigen injections within 30 days before first IMP administration and until the end of the study

Where it is running

• Hopital Henri Mondor — Créteil, France (enrolling)
• Hôpital Cochin — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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