[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100186017":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":29,"centralContacts":29,"locations":41,"responsibleParty":69,"collaborators":73,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":29,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":29,"overallStatus":118,"whyStopped":29,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Muhimbili University of Health and Allied Sciences","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"2 injections of DNA administered by Zetajet","EXPERIMENTAL","This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg\u002Fml",[13,14,15],"Biological: HIVIS DNA vaccine","Device: Zetajet","Biological: Modified Vaccinia Ankara (MVA-CDMR)",{"label":17,"type":10,"description":18,"interventionNames":19},"2 injections DNA by Zetajet and electroporation","This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg\u002Fml followed by electroporation using the Derma Vax device.",[13,14,20,15],"Device: Derma Vax Electroporation",{"label":22,"type":10,"description":23,"interventionNames":24},"1 injection DNA by Zetajet and electroporation","This arm will receive 600 micrograms of HIVIS DNA given in 1 injection using the Zetajet device the injection will comprise of 0.1 ml at a concentration of 6mg\u002Fml followed by electroporation using the Derma Vax device.",[13,14,20,15],[26,31,35,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":29},"BIOLOGICAL","HIVIS DNA vaccine",null,[22,17,9],{"type":32,"name":33,"description":29,"armGroupLabels":34,"otherNames":29},"DEVICE","Zetajet",[22,17,9],{"type":32,"name":36,"description":29,"armGroupLabels":37,"otherNames":29},"Derma Vax Electroporation",[22,17],{"type":27,"name":39,"description":29,"armGroupLabels":40,"otherNames":29},"Modified Vaccinia Ankara (MVA-CDMR)",[22,17,9],[42,53,61],{"facility":43,"status":29,"city":44,"state":29,"zip":29,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":29},"Instituto Nacional de Saude","Maputo","Mozambique","MZ",{"type":48,"coordinates":49},"Point",[50,51],32.58322,-25.96553,{"lat":51,"lon":50},{"facility":5,"status":29,"city":54,"state":29,"zip":29,"country":55,"countryCode":29,"cosmosGeoPoint":56,"geoPoint":60,"contacts":29},"Dar es Salaam","Tanzania",{"type":48,"coordinates":57},[58,59],39.26951,-6.82349,{"lat":59,"lon":58},{"facility":62,"status":29,"city":63,"state":29,"zip":29,"country":55,"countryCode":29,"cosmosGeoPoint":64,"geoPoint":68,"contacts":29},"Mbeya Medical Research Programme","Mbeya",{"type":48,"coordinates":65},[66,67],33.45,-8.9,{"lat":67,"lon":66},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Patricia Jane Munseri","Prof Eligius Lyamuya",[74,76,78,81,84,86,88,90,93],{"name":75,"class":6},"Swedish Institute for Infectious Disease Control",{"name":77,"class":6},"Karolinska Institutet",{"name":79,"class":80},"US Military HIV Research Program","NETWORK",{"name":82,"class":83},"Medical Research Council","OTHER_GOV",{"name":85,"class":83},"National Institute for Medical Research, Tanzania",{"name":87,"class":6},"Ludwig-Maximilians - University of Munich",{"name":89,"class":6},"Imperial College London",{"name":91,"class":92},"Mbeya medical research program","UNKNOWN",{"name":94,"class":83},"Instituto Nacional de Saúde, Mozambique","100186017","phase-2-a-phase-ii-trial-to-assess-the-safety-and-immunogenicity-of-dna-priming-administered-by-the-id-zetajet-with-or-without-id-derma-vax-electroporation-followed-by-im-mva-boosting-in-healthy-volunteers-in-tanzania-and-mozambique-100186017",false,"NCT01697007","A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique","TaMoVac II","Inclusion Criteria:\n\n* Willing to undergo counselling and HIV testing.\n* Have a negative antigen\u002Fantibody ELISA for HIV infection.\n* Able to give informed consent.\n* Basic abilities to read and write.\n* Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.\n* Resident of the region where the study is taking place.\n* At low risk of HIV infection.\n* Verbal assurances for adequate birth control measures.\n* Healthy as evidenced by clinical and laboratory measures\n\nExclusion Criteria:\n\n* At risk of HIV infection.\n* Active tuberculosis.\n* A history of immunodeficiency, ongoing medical and\u002For psychiatric condition and\u002For chronic illness requiring continuous or frequent medical intervention.\n* Autoimmune disease.\n* Hives and severe eczema.\n* Substance abuse problems.\n* History of grand-mal epilepsy.\n* Received blood or blood products or immunoglobulins in the past 3 months.\n* Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.\n* Use of experimental therapeutic agents within 30 days of study entry.\n* History of cardiac disease",true,"ALL","18 Years","40 Years",{"count":107,"type":108},198,"ACTUAL","INTERVENTIONAL",[111],"PHASE2","Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.",[114,115,116,117],"Vaccines","HIV","Safety","Immunogenicity","COMPLETED","2015-06-26",{"date":121,"type":122},"2015-06-29","ESTIMATED",{"date":124,"type":29},"2012-11",{"date":126,"type":108},"2015-06",{"name":5,"class":6},3]