[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487925":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":104,"collaborators":35,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":35,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":35,"studyType":120,"phases":121,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":137,"whyStopped":35,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Gylden Pharma Ltd","INDUSTRY",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"PepGNP-COVID19 (One vaccination)","EXPERIMENTAL","One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)",[13],"Biological: PepGNP-COVID19 (One vaccination)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (One vaccination)","PLACEBO_COMPARATOR","One vaccination of WFI administered on Day 0 (50 µl per dose)",[19],"Other: Water for injection (One vaccination)",{"label":21,"type":10,"description":22,"interventionNames":23},"PepGNP-COVID19 (Two vaccinations)","Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)",[24],"Biological: PepGNP-COVID19 (Two vaccinations)",{"label":26,"type":16,"description":27,"interventionNames":28},"Placebo (Two vaccinations)","Two vaccinations of WFI administered with on Day 0 \\& Day 21 (50 µl per dose)",[29],"Other: Water for injection (Two vaccinations)",[31,36,43,46],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","One dose with 7.5 nmol total peptide\u002Fdose with 47.8ug gold base particle in 50 µl WFI",[9],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"OTHER","Water for injection (One vaccination)","Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose",[15],[42],"WFI",{"type":32,"name":21,"description":44,"armGroupLabels":45,"otherNames":35},"Two vaccinations with 7.5 nmol total peptide\u002Fdose with 47.8ug gold base particle in 50 µl WFI",[21],{"type":37,"name":47,"description":39,"armGroupLabels":48,"otherNames":49},"Water for injection (Two vaccinations)",[26],[42],[51],{"name":52,"affiliation":53,"role":54},"Alberto R Edison, MD","Research Institute for Tropical Medicine","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":35,"email":59},"CONTACT","+63 (040) 471-0996","edisonalberto@rocketmail.com",{"name":61,"role":57,"phone":62,"phoneExt":35,"email":63},"Kassandra G Navea, BS","+63 9454099847","navea.kassandra@gmail.com",[65,85],{"facility":66,"status":35,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Health Index Multispecialty Clinic, Barangay Toclong 2B","Imus","Cavite","4104","Philippines","PH",{"type":73,"coordinates":74},"Point",[75,76],120.93667,14.42972,{"lat":76,"lon":75},[79,81],{"name":61,"role":57,"phone":80,"phoneExt":35,"email":63},"+639454099847",{"name":82,"role":57,"phone":83,"phoneExt":35,"email":84},"Coreign A Domingo, AB Psy","+63468877356","coreign17@gmail.com",{"facility":86,"status":35,"city":87,"state":88,"zip":89,"country":70,"countryCode":71,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Tropical Disease Foundation","Makati City","National Capital Region","1229",{"type":73,"coordinates":91},[92,93],121.03269,14.55027,{"lat":93,"lon":92},[96,100],{"name":97,"role":57,"phone":98,"phoneExt":35,"email":99},"Charissa Fay Corazon B Tabora, BS","+639178294349","cbtabora@gmail.com",{"name":101,"role":57,"phone":102,"phoneExt":35,"email":103},"Sarah Jane T Lo, BS","+639393090547","losarahjane20@gmail.com",{"type":105,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100487925","phase-1-next-generation-t-cell-vaccine-against-coronavirus-disease-covid-19-100487925",false,"NCT05633446","Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)","A Phase I-II, Blinded, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults","Inclusion Criteria:\n\n1. Healthy volunteers aged 18 to 75 years on the day of inclusion\n2. Participant signed informed consent\n3. Residing in Philippines.\n4. A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.\n5. A participant can be included providing, the participant haven't received any vaccination against COVID-19 in the past, or if the participant had already received any of the following licensed vaccines against COVID-19: Oxford\u002FAstraZeneca; Pfizer\u002FBioNTech; Moderna; or J\\&J\u002FJanssen, with the participants last dose received at least 6 months prior the inclusion in this trial.\n\nExclusion Criteria:\n\n1. Participant is pregnant, lactating, or of childbearing potential\n2. Participation in the 6 months preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure\n3. Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study.\n4. Receipt of any vaccine in the three months preceding the first trial vaccination or planned receipt of any vaccine in the 6 months following last trial vaccination.\n5. Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination\n6. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months\n7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy\n8. Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C\n9. Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines or to a vaccine containing any of the same substances\n10. Current alcohol abuse or drug addiction (reported or suspected)\n11. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion\n12. Thrombocytopenia or any coagulation disorder\n13. Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (i.e. in the employment of the clinical trial sites).\n14. Refusal to be informed if relevant results concerning the participant's health are revealed",true,"ALL","18 Years","75 Years",{"count":118,"type":119},110,"ESTIMATED","INTERVENTIONAL",[122,123],"PHASE1","PHASE2","The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.",[126,127,128],"Coronavirus","SARS-CoV-2 Infection","COVID-19",[126,130,128,131,132,133,134,135,136],"SARS-CoV-2","T-cell priming","COVID vaccine","Nanoparticle","T cell","Cellular immunity","T-cell vaccine","NOT_YET_RECRUITING","2025-02-21",{"date":140,"type":141},"2025-02-24","ACTUAL",{"date":143,"type":119},"2025-09-01",{"date":145,"type":119},"2026-12-01",{"name":5,"class":6},2]