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.

ANRS0407s - LKV.Cov40

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

2024-02-01

2025-09-01

2025-09-01

Not yet recruiting

Early phase I

240

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open label study. Immunological assessors, only, will remain blinded.'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-02-16