[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rokote Laboratories Finland Oy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100624969","phase-1-effect-of-cov2-vaccine-formulation-on-the-ability-to-generate-antibodies-against-coronavirus-that-causes-covid-19-100624969",false,"NCT07416539","Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19","A Phase 1a, Single-Blind, Randomized Comparative Clinical Trial Evaluating the Impact of Vaccine Formulation on the Safety and Immunogenicity of the COV2 Vaccine in Healthy Adults","Inclusion criteria\n\n* Has voluntarily signed the written informed consent\n* Male or female aged ≥18 to ≤75 years\n* Good general health based upon the results of the medical history, laboratory tests, physical examination, ENT clinical examination, and vital signs as assessed by the investigator\n* Prior vaccination with at least two doses of any COVID-19 vaccine with last dose obtained ≥180 days before the planned baseline (Day 0) visit\n* Has a personal smartphone, tablet or computer with internet access, and is considered willing and able to report the data in the ePRO and to comply with the reporting timelines\n* Willing and able to comply with the instructions to participants\n* Not of childbearing potential or willing and able to use a highly effective contraception method consistently and correctly during the entire trial\n\nExclusion criteria\n\n* Pregnant, planning to become pregnant, or breastfeeding women\n* Received any investigational drug \\\u003C 180 days prior baseline\n* Antigen positivity or PCR confirmed SARS-CoV-2 infection less than 180 days apart from screening or during screening and\u002For baseline\n* Any SARS-CoV vaccination was administrated \\\u003C 180 days prior the planned baseline (Day 0) visit\n* Any other vaccination within 60 days prior the planned baseline (Day 0) visit\n* Administration of immunoglobulins or blood products within 90 days prior baseline\n* Current use of immunosuppressant medication (except topical and inhaled steroids, which are permitted in indications not prohibited in the exclusion criteria)\n* Use of steroid nasal sprays within 30 days prior to screening\n* Use of any oral or nasal decongestants within 7 days prior to screening\n* Any confirmed or suspected immunodeficient state\n* Chronic respiratory diseases (except treatment -controlled asthma)\n* Severe chronic cardiovascular and endocrinological diseases (e.g., medicine or insulin treated diabetes), liver and renal insufficiency or serious psychiatric diseases\n\n  \\- Medication for elevated cholesterol or blood pressure or dietary treated diabetes or hypothyreosis are not exclusion criteria\n* Any diagnosed disease or abnormality in the nasal or upper respiratory tract, such as acute\u002Fchronic rhinosinusitis; nasal polyposis; mucosal pathology or tumor of nasal cavity, pharynx or nasopharynx; significant obstructive nasal deformity; recurrent epistaxis; sleep apnea; anosmia\n\n  \\- History of adenoidectomy and\u002For tonsillectomy are not exclusion criteria\n* Severe obesity (BMI ≥ 35)\n* Cancer treated within 5 years\n* Known allergy\u002Fhypersensitivity to any ingredients of the COV2 vaccine\n* Previous anaphylactic reaction\n* Any clinically significant abnormal finding in the screening laboratory tests\n* Inability to sign ICF or to understand and comply with trial related instructions and requirements\n* Individuals who are employees of, or directly affiliated with, the sponsor, or site staff or their immediate family members.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein.\n\nParticipants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28.\n\nThis trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.",[28,29],"COVID - 19","SARS CoV-2",[31,32,33,34],"nasal vaccine","COVID-19","adenoviral vector-based vaccines","Sars CoV-2","RECRUITING","2026-02-18",{"date":38,"type":39},"2026-02-20","ACTUAL",{"date":41,"type":39},"2026-02-10",{"date":43,"type":22},"2026-11",{"name":45,"class":46},"Rokote Laboratories Finland Oy","INDUSTRY",""]