[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebola-virus-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebola-virus-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,68,88,116,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100580769","phase-3-ebola-post-exposure-prophylaxis-100580769",false,"NCT06841614","EBOla Post-Exposure Prophylaxis","Evaluation of the Efficacy of a Post-exposure Prophylaxis (PEP) Strategy in Contacts at High Risk of Developing Ebola Virus Disease (EVD)","EBO-PEP","Inclusion criteria\n\n* Last high-risk contact within the last 5 days\n* No sign or symptoms of EVD\n* Signed and dated informed consent from participants over the age of majority to participate in the trial or from a representative of parental authority for minor participants.\n\nNon-inclusion criteria\n\n* History of vaccination with Ervebo or any other EVD vaccine within the last 5 years (self-reported by the participant)\n* History of confirmed EVD within the last 5 years (self-reported by the participant)\n* Hypersensitivity to any of the experimental medical products (IMP) or their excipients (self-reported by the participant)\n* Participation in another therapeutic or vaccine trial for EVD\n* Any other reason that, at the investigator's discretion, could compromise the participant's safety and cooperation in the trial.","ALL",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.\n\nThe trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD.\n\nParticipants will be randomized (1:1) into one of two trial arms:\n\n* Arm 1 (ERV): Ervebo D0 (72 million PFU IM)\n* Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg\u002Fkg) D0 + Ervebo D56 (revaccination)\n\nDefinition of high-risk:\n\nDirect contact with a person with EBOV PCR-confirmed EVD with diarrhea, vomiting or external bleeding (\"wet symptoms\"), or with their body fluids; Direct contact with the dead body of a person with confirmed or probable EVD; Needlestick with a syringe contaminated by the blood of a person with confirmed or probable EVD; Or a child born to or breastfed by an individual with EVD\n\nTrial follow-up All participants are monitored daily for a minimum of 21 days.\n\nSome visits are conducted in person at the investigation site, also called the Post-Exposure Prophylaxis (PEP) center:\n\n* at Day 5, Day 10, and Day 21 for the ERV arm,\n* at Day 5, Day 10, Day 21, and Day 56 for the ERV+IMZ arm. Other visits are conducted at home or by phone, in collaboration with the Ministry of Health's surveillance team.\n\nParticipants in the ERV+IMZ arm have an in-person visit at Day 56 to be revaccinated with the Ervebo vaccine to compensate for potential inhibition of the vaccine response when Ervebo is administered simultaneously with Inmazeb.\n\nParticipants in the ERV arm have a phone visit at Day 56. For all participants, a phone visit is scheduled at Day 60. It corresponds to the last visit for all trial participants.\n\nFollow-up in Case of Hospitalisation In case of clinical signs suggestive of EVD, participants enter the suspected case management pathway at the Ebola Treatment Center (ETC).\n\nIf EVD is confirmed by EBOV PCR, participants are allowed at the ETC, and their study samples are discontinued. They continue to be followed by the research team, and daily data are collected throughout their stay at the ETC until they are discharged alive or deceased. The day of discharge from the ETC marks the end of follow-up in the study for these participants.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nIf EVD is not confirmed, participants continue to be followed up by the PEP center according to the protocol.",[26],"Ebola Virus Disease",[26,28,29,30],"EBOV","High-Risk contact","Post-Exposure Prophylaxis","NOT_YET_RECRUITING","2026-01-21",{"date":34,"type":35},"2026-01-22","ACTUAL",{"date":37,"type":20},"2026-09",{"date":39,"type":20},"2028-08-01",{"name":41,"class":42},"ANRS, Emerging Infectious Diseases","OTHER_GOV",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100454803","phase-2-impact-of-delay-between-administration-of-inmazeb-administration-and-vaccination-by-ervebo-on-vaccine-immune-response-on-healthy-volunteers-100454803","NCT05202288","Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers","Phase IIa, Randomized, Open-label, Parallel-group Trial to Assess the Immunogenicity, Safety and Tolerability of Ervebo Vaccine Administered With Inmazeb to Healthy Adult Volunteers.","Inclusion Criteria:\n\n* Available for the duration of the protocol follow-up;\n* Consent to participate ;\n* Agreed not to participate in another clinical research study until the end of the trial follow-up.\n\nExclusion Criteria:\n\n* Prior history of EVD (self-reported);\n* Previous vaccination with r-VSV-ZEBOV or any other Ebola vaccine (self-reported);\n* Previous administration of Ebola antibody;\n* HIV-1 and\u002For 2 positive serology;\n* Pregnant women (positive pregnancy test);\n* Breastfeeding women;\n* To the opinion of the investigator, any clinically significant acute\u002Fchronic condition that would limit the participant\\'s ability to meet the requirements of the study protocol;\n* Taking Immunosuppressive therapy;\n* Participation in another clinical research study within the last 30 days;\n* Allergy to any component of the vaccine or Mabs;\n* Person deprived of freedom by a judicial or administrative decision;\n* Any other reason that, at the investigator\\'s discretion, would compromise the participant\\'s safety and cooperation in the trial.",true,"18 Years",{"count":54,"type":20},132,[56],"PHASE2","Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination around a recovered patient.\n\nHowever, tools to fight the spread of the disease are being made available to countries affected by EVD. A vaccine (Ervebo), developed by the Merck laboratory, demonstrated its efficacy in protecting contacts and contacts of contacts in the \"Ebola That's Enough\" trial and two monoclonal antibodies (Mabs) have demonstrated their efficacy in reducing mortality in patients with EVD: REGN-E3B (Inmazeb) and Mab114 (Ebanga).\n\nThe question of their use in post-exposure prophylaxis (PEP), defined as the treatment of contacts at very high risk of contracting EVD, is essential. Vaccination with Ervebo does not appear to be a good standalone option for PEP, particularly because antibody synthesis is delayed, and the vaccine is likely to be inactive for 10 days after administration. Monoclonal antibodies, on the other hand, seem to be a promising avenue in this indication because of their rapid action on the inhibition of virus entry into the cell.\n\nMoreover, Ervebo vaccine expresses the viral target recognized by mAbs, GP EBOV. It is therefore possible that the vaccine response (production of vaccine antibodies) is inhibited by mAbs, which bind to GP EBOV and prevent vaccine replication, particularly in the case of concomitant administration.\n\nHowever, no data on vaccine efficacy in combination are available. The question of the interaction between the monoclonal antibody and Ervebo and the delay between the administration of these two strategies remains unresolved.\n\nThe hypothesis of this trial is that Ervebo vaccine efficacy is diminished with the concomitant administration of a monoclonal antibody, especially if this administration is close (short time between Mabs and vaccination). We hypothesize that with an optimal delay between Mabs and vaccination, the immunogenicity of the vaccine when administered with monoclonal antibodies could be non-inferior to the vaccine alone, thus providing optimal short and long term protection.\n\nThe main objective of this study is to evaluate the extent of effect, if any, of Inmazeb administration on vaccine-induced neutralizing antibody responses to Zaire Ebola virus by Ervebo vaccine. If an interaction is observed, this will possibly enable determination of the time interval required between the administration of Inmazeb and Ervebo vaccine.\n\nThe trial will have 6 arms. A control arm of vaccination alone will serve to characterize the immune response to the vaccine and it will be used as a comparator of vaccine immune response in the intervention arms. A control arm of mAb alone will serve to characterize the pharmacokinetic profile of mAb in the Guinean population. The 4 arms including different doses of Inmazeb plus vaccination were designed to mimic a time interval between Ervebo and Inmazeb administration (15, 57 and 169 days after Inmazeb).",[26],[60,61],"Post Exposure Prophylaxis","Ebola vaccine",{"date":34,"type":35},{"date":64,"type":20},"2027-01",{"date":66,"type":20},"2027-08",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":85,"locationsCount":4},"100330012","r3470-3471-3479-regn-eb3-expanded-access-protocol-eap-for-treatment-of-ebola-virus-disease-100330012","NCT03576690","R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease","Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for the Treatment of Ebola Virus Disease","Key Inclusion Criteria:\n\n* Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic\n* Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations\n* REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol\n* Children of any age will be eligible for enrollment, as defined in the protocol\n* Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol\n\nKey Exclusion Criteria:\n\n* Negative EBOV diagnostic test result\n* A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol\n* Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions\n* Eligible for an ongoing randomized clinical trial with REGN-EB3\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply","EXPANDED_ACCESS","Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).",[26],[79,80],"Positive Ebola Virus (EBOV) diagnostic test","symptomatic","AVAILABLE","2025-11-20",{"date":84,"type":35},"2025-11-24",{"name":86,"class":87},"Regeneron Pharmaceuticals","INDUSTRY",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100525829","phase-3-safety-and-immunogenicity-of-ervebo-and-zabdeno-booster-vaccines-against-ebola-virus-following-previous-vaccination-with-the-zabdenomvabea-or-ervebo-vaccine-schedules-in-drc-100525829","NCT06126822","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT","EBO-BOOST","Inclusion Criteria:\n\n* Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\\&J) more than 4 months prior to recruitment\n* Subjects between 18 and 50 years of age at time of randomization\n* Subject must be willing and able to provide informed consent\n* The subject must be in possession of an identification card (or other identification document)\n* Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination\n* Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant\n\nExclusion Criteria:\n\n* Participants who previously experienced active Ebola Virus Disease (EVD)\n* Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment\n* Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine\n* Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\\&J) vaccine\n* Administration of immunoglobulins and\u002For any blood products within three months prior to recruitment.\n* Fever (\\>38°C) within last 24 hours prior to recruitment.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.\n* Severe and\u002For uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed)\n* History of anaphylaxis, allergic disease or reactions to any component of the study vaccines\n* History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture\n* History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)\n* Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data\n* Suspected or known alcohol or drug dependency\n* Subject is not readily available by telephone, email or physical address\n\nThe non-vaccinated control group will also adhere to all the above in- and exclusion criteria, with exemption of:\n\n* Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination\n* Subjects who received either the Ervebo® vaccine, or the full Zabdeno, Mvabea® vaccine regimen more than 4 months prior to recruitment\n\nThe latter is rather introduced as an additional exclusion criteria:\n\n* Subjects who received either the Ervebo® vaccine or the full Zabdeno, Mvabea® vaccine regimen","50 Years",{"count":98,"type":20},624,[23],"The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno\u002FMvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules.\n\nParticipants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.",[26],[103],"Ebola vaccines","RECRUITING","2025-03-13",{"date":107,"type":35},"2025-03-18",{"date":109,"type":35},"2025-02-25",{"date":111,"type":20},"2026-10",{"name":113,"class":114},"Institute of Tropical Medicine, Belgium","OTHER",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":135,"locationsCount":4},"100444418","open-label-expanded-access-for-ebola-infected-patients-to-receive-human-mab-ansuvimab-as-therapeutic-or-for-hr-pep-100444418","NCT05067166","Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP","Open-Label, Expanded Access Protocol of a Human Monoclonal Antibody, Ansuvimab (mAb114), Administered As a Therapeutic to Ebola-Infected Patients or As a High-Risk Ebola Post-Exposure Prophylaxis","Inclusion Criteria:\n\n* Male or female with laboratory confirmed (based on local standard of care) EBOV infection or with recent high-risk EBOV exposure as determined by a treating Physician or designee.\n* Able to provide proof of identity to the satisfaction of the clinical team\n* Able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations.\n\nExclusion Criteria:\n\n\\- Any medical condition that, in the opinion of the Treating Physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol.","The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under an expanded access protocol. Ansuvimab is administered at 50 mg\u002Fkg as a single intravenous (IV) infusion",[26],[126,127,128,129,130,131],"EBANGA","orthoebolavirus zairense, EBOV","ansuvimab","Zaire ebolavirus, EVD","Compassionate Use","Ebola","2024-12-12",{"date":134,"type":35},"2024-12-17",{"name":136,"class":87},"Ridgeback Biotherapeutics, LP",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":96,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100561233","phase-4-safety-and-immunogenicity-of-rvsvg-zebov-gp-vaccination-when-dosed-concurrently-with-mrna-covid-19-vaccine-booster-doses-100561233","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.",{"count":145,"type":20},72,[147],"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.",[26,150],"COVID-19","2024-09-09",{"date":153,"type":35},"2024-09-19",{"date":155,"type":20},"2024-10",{"date":157,"type":20},"2025-05",{"name":159,"class":114},"University of Birmingham"]