[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624969":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":72,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":23,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":23,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Rokote Laboratories Finland Oy","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COV2 vaccine in Formulation A","EXPERIMENTAL","COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.",[13],"Biological: COVID-19 Vaccines",{"label":15,"type":10,"description":16,"interventionNames":17},"COV2 vaccine in formulation B","COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.",[13],[19,24],{"type":20,"name":21,"description":11,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","COVID-19 Vaccines",[9],null,{"type":20,"name":21,"description":16,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"affiliation":5,"role":29},"Seppo Ylä-Herttuala","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Terhi Reunama","CONTACT","+358 40 510 5560","terhi.reunama@rokote.com",{"name":37,"role":33,"phone":38,"phoneExt":23,"email":39},"Erkko Ylösmäki","+358 40 5836604","erkko.ylosmaki@rokote.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Kuopio University Hospital, ENT policlinic","RECRUITING","Kuopio","Northern Savonia","70210","Finland","FI",{"type":50,"coordinates":51},"Point",[52,53],27.67703,62.89238,{"lat":53,"lon":52},[56,60,64,67,70],{"name":57,"role":33,"phone":58,"phoneExt":23,"email":59},"Laura Jääskeläinen, Registered Nurse","+358 40 7741104","laura.jaaskelainen@satucon.fi",{"name":61,"role":33,"phone":62,"phoneExt":23,"email":63},"Tuula Taskinen, Registered Nurse","+358 41 326 5842","tuula.taskinen@pshyvinvointialue.fi",{"name":65,"role":66,"phone":23,"phoneExt":23,"email":23},"Heikki Löppönen, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":68,"role":69,"phone":23,"phoneExt":23,"email":23},"Sakari Nieminen, MD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":23,"phoneExt":23,"email":23},"Butoto Kazera, MD",{"type":73,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[75,77],{"name":76,"class":6},"Oy Medfiles Ltd",{"name":78,"class":79},"Estimates OY","UNKNOWN","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":92,"type":93},20,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99,100],"COVID - 19","SARS CoV-2",[102,103,104,105],"nasal vaccine","COVID-19","adenoviral vector-based vaccines","Sars CoV-2","2026-02-18",{"date":108,"type":109},"2026-02-20","ACTUAL",{"date":111,"type":109},"2026-02-10",{"date":113,"type":93},"2026-11",{"name":5,"class":6},1]