[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535730":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":34,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":34,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio)","EXPERIMENTAL","Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio). If randomized to receive LD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine non adjuvanted (1:1) in part 2.\n\nFollowing a substancial amendment the randomization to mRNA vaccine has been removed from study design",[13],"Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)",{"label":15,"type":10,"description":16,"interventionNames":17},"2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio)","LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive LD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine adjuvanted (1:1) in part 2.\n\nFollowing a substancial amendment the randomization to mRNA vaccine has been removed from study design",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio)","High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine non adjuvanted (1:1) in part 2.\n\nFollowing a substancial amendment the randomization to mRNA vaccine has been removed from study design",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine","HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine adjuvanted (1:1) in part 2.\n\nFollowing a substancial amendment the randomization to mRNA vaccine has been removed from study design",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","CD40.RBDv vaccin (SARS-Cov2 Vaccin)","1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))",[9,15,19,23],[33],"COVID-19 mRNA vaccine",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Yves Levy, MD","CONTACT","+33149814442","yves.levy@aphp.fr",[42,58],{"facility":43,"status":44,"city":45,"state":34,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hopital Henri Mondor","RECRUITING","Créteil","94000","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.46569,48.79266,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":34,"phoneExt":34,"email":34},"Jean Daniel Lelièvre, MD",{"facility":59,"status":44,"city":60,"state":34,"zip":61,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hôpital Cochin","Paris","75014",{"type":50,"coordinates":63},[64,65],2.3488,48.85341,{"lat":65,"lon":64},[68],{"name":69,"role":38,"phone":34,"phoneExt":34,"email":34},"Odile Launay, MD",{"type":71,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[73,76],{"name":74,"class":75},"Vaccine Research Institute (VRI), France","UNKNOWN",{"name":77,"class":75},"EnnoDc (previously known as LinKinVax)","100535730","phase-1-safety-and-immunogenicity-of-a-sub-unit-protein-cd40rbdv-bivalent-covid-19-vaccine-adjuvanted-or-not-as-a-booster-in-volunteers-100535730",false,"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\u002F2 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.","Inclusion Criteria:\n\n* Healthy volunteers Age ≥18 and \\\u003C85\n* Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures\n* 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\n* Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline phosphatase\n* Normal haematology lab values\n* Negative virology assessment\n* Normal Urine testing\n* Volunteers must meet the eligibility criteria in the approved package labelling of the active comparator\n* 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\n\nExclusion Criteria:\n\n* Acute febrile infection within the previous 72 hours and\u002For presenting symptoms suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days\n* Immunosuppressive medications received within last three months before first IMP administration or within 6 months for chemotherapies\n* Immunoglobulins within 90 days before first IMP administration\n* Blood products within 120 days before first IMP administration\n* Any medical condition, such as cancer, that might impair the immune response\n* Use of any experimental therapy\n* 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\n* Currently pregnant or breastfeeding\n* History of severe adverse events following vaccine administration\n* Any bleeding disorder considered as a contraindication to an intramuscular injection\n* A condition that requires active medical intervention or monitoring to avert grave danger to Asthma other than mild, well-controlled asthma.\n* Hypertension\n* BMI ≥ 40 kg\u002Fm2; ≤ 18 kg\u002Fm2; or BMI ≥ 35 kg\u002Fm2 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\n* Malignancy\n* Asplenia\n* Seizure disorder\n* History of hereditary angioedema acquired angioedema, or idiopathic angioedema\n* History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up\n* History of autoimmune disease\n* Any medical, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence\n* Psychiatric condition that precludes compliance with the protocol.\n* 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\n* Vaccines that are not live attenuated vaccines and were received within 21 days prior to first IMP administration\n* Allergy treatment with antigen injections within 30 days before first IMP administration and until the end of the study",true,"ALL","18 Years","84 Years",{"count":90,"type":91},215,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine.\n\nThe main questions that will be studied are :\n\n* Is the CD40.RBDv (adjuvanted or not) safe ?\n* 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",[98],"COVID-19",[100,98],"Vaccine","2025-04-23",{"date":103,"type":104},"2025-04-25","ACTUAL",{"date":106,"type":104},"2024-05-27",{"date":108,"type":91},"2025-09",{"name":5,"class":6},2]