[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561233":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":50,"collaborators":52,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":48,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":48,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":48,"overallStatus":82,"whyStopped":48,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":48},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Receive an intramuscular injection of a placebo concurrently with a dose of rVSV∆G-ZEBOV-GP vaccine",[13,14],"Biological: 1mL saline solution","Biological: rVSV∆G-ZEBOV-GP",{"label":16,"type":17,"description":18,"interventionNames":19},"Concurrent vaccination","EXPERIMENTAL","Receive an intramuscular dose of BioNTech - Pfizer COVID-19 concurrently with a dose of rVSV∆G-ZEBOV-GP vaccine",[20,14],"Biological: BioNTech - Pfizer COVID-19 vaccine",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","BioNTech - Pfizer COVID-19 vaccine","Vaccine for protection from COVID-19",[16],[28],"Cominarty",{"type":23,"name":30,"description":9,"armGroupLabels":31,"otherNames":32},"1mL saline solution",[9],[33],"rVSV∆G-ZEBOV-GP",{"type":23,"name":33,"description":35,"armGroupLabels":36,"otherNames":37},"Vaccine for protection from Zaire Ebola virus",[16,9],[38],"Ervebo",[40],{"name":41,"affiliation":5,"role":42},"Christopher Green, PhD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Julien Nyombayire, MD, MSc","CONTACT","+250 252 503 233",null,"jnyombayire@rzhrg-mail.org",{"type":51,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[53,56,58],{"name":54,"class":55},"Project San Francisco","UNKNOWN",{"name":57,"class":6},"Rwanda Biomedical Centre",{"name":59,"class":60},"Merck Sharp & Dohme LLC","INDUSTRY","100561233","phase-4-safety-and-immunogenicity-of-rvsvg-zebov-gp-vaccination-when-dosed-concurrently-with-mrna-covid-19-vaccine-booster-doses-100561233",false,"NCT06587503","Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses","EbolaCov: A Phase IV, Single-centre, Single-blinded, Randomized Controlled Trial to Assess Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With mRNA COVID-19 Vaccine Booster Doses in Healthy African Adults","Inclusion Criteria:\n\n* Healthy male and female adults between ages 18-50 years, who are able and willing to provide written informed consent and will comply with the study requirements.\n* Already completed a primary course of COVID-19 immunisation (any World Health Organisation approved primary immunisation course is acceptable).\n\nExclusion Criteria:\n\n* Unwilling or unable to provide written informed consent to take part\n* Unwilling or unable to comply with study procedures\n* Previously received an Ebola vaccine or previous exposure to Ebola virus (including serological and clinical diagnoses, irrespective of viral strain)\n* Not received a primary course of COVID-19 immunisation\n* History of any suspected or confirmed disorder of the immune system that, in the opinion of the Investigators, might impair the results of the study\n* Use of immunosuppressant medication within the past 6 months (excluding topical steroids or oral steroid courses lasting \\\u003C7 days)\n* Current diagnosis or treatment of cancer (unless non-melanomatous skin cancer)\n* Have a bleeding disorder deemed significant by study doctor\n* Pregnant or breast-feeding females\n* Able to avoid close contact with vulnerable individuals, including via high-risk blood and bodily fluids for 6 weeks following vaccination to reduce the risk of transmission to vulnerable individuals (e.g. immuno-compromised individuals, individuals receiving immunosuppressive therapy, pregnant or breast-feeding women, children \\\u003C1 year of age).\n* Unable to prevent contact of their blood or bodily fluids with farm animals in the 6 weeks following vaccination\n* Plan to donate blood in the 6 weeks following vaccination\n* Hypersensitivity to any active substances, excipients, or rice protein.\n* History of anaphylaxis to any component of vaccine formulation.",true,"ALL","18 Years","50 Years",{"count":73,"type":74},72,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","Concurrent vaccination scheduling for key target populations in Rwanda, such as healthcare workers, may confer significant advantages in the provision of vaccine coverage to several infectious diseases. This is a phase IV vaccine trial that looks to establish if two licenced vaccines, the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid (mRNA) COVID vaccine for protection against SARS-CoV-2 virus, given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response.",[80,81],"Ebola Virus Disease","COVID-19","NOT_YET_RECRUITING","2024-09-09",{"date":85,"type":86},"2024-09-19","ACTUAL",{"date":88,"type":74},"2024-10",{"date":90,"type":74},"2025-05",{"name":5,"class":6}]