Hemorrhagic Fever, Ebola Clinical Trial
Official title:
Open-Label, Expanded Access Protocol of a Human Monoclonal Antibody, Ansuvimab (mAb114), Administered as an Investigational Therapeutic to Ebola-Infected Patients or as a High-Risk Ebola Post-Expo
NCT number | NCT05067166 |
Other study ID # | Ansuvimab EAP-2020-DRC |
Secondary ID | Ansuvimab EAP-DR |
Status | Available |
Phase | |
First received | |
Last updated |
The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under expanded access. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion
Status | Available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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. - Able to provide proof of identity to the satisfaction of the clinical team - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Institut National de Recherche Biomedical | Beni | North Kivu |
Congo, The Democratic Republic of the | Institut National de Recherche Biomédicale | Butembo | North Kivu |
Congo, The Democratic Republic of the | Institut National de Recherche Biomedical | Mbandaka | Equateur |
Sierra Leone | University of Sierra Leone Teaching Hospital Complex | Freetown |
Lead Sponsor | Collaborator |
---|---|
Ridgeback Biotherapeutics, LP | Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo |
Congo, The Democratic Republic of the, Sierra Leone,
Bebell LM, Riley LE. Ebola virus disease and Marburg disease in pregnancy: a review and management considerations for filovirus infection. Obstet Gynecol. 2015 Jun;125(6):1293-1298. doi: 10.1097/AOG.0000000000000853. — View Citation
Broadhurst MJ, Brooks TJ, Pollock NR. Diagnosis of Ebola Virus Disease: Past, Present, and Future. Clin Microbiol Rev. 2016 Oct;29(4):773-93. doi: 10.1128/CMR.00003-16. — View Citation
Cherif MS, Koonrungsesomboon N, Kasse D, Cisse SD, Diallo SB, Cherif F, Camara F, Kone A, Avenido EF, Diakite M, Diallo MP, Le Gall E, Cisse M, Karbwang J, Hirayama K. Ebola virus disease in children during the 2014-2015 epidemic in Guinea: a nationwide cohort study. Eur J Pediatr. 2017 Jun;176(6):791-796. doi: 10.1007/s00431-017-2914-z. Epub 2017 Apr 25. — View Citation
Corti D, Misasi J, Mulangu S, Stanley DA, Kanekiyo M, Wollen S, Ploquin A, Doria-Rose NA, Staupe RP, Bailey M, Shi W, Choe M, Marcus H, Thompson EA, Cagigi A, Silacci C, Fernandez-Rodriguez B, Perez L, Sallusto F, Vanzetta F, Agatic G, Cameroni E, Kisalu N, Gordon I, Ledgerwood JE, Mascola JR, Graham BS, Muyembe-Tamfun JJ, Trefry JC, Lanzavecchia A, Sullivan NJ. Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science. 2016 Mar 18;351(6279):1339-42. doi: 10.1126/science.aad5224. Epub 2016 Feb 25. — View Citation
Fischer WA 2nd, Vetter P, Bausch DG, Burgess T, Davey RT Jr, Fowler R, Hayden FG, Jahrling PB, Kalil AC, Mayers DL, Mehta AK, Uyeki TM, Jacobs M. Ebola virus disease: an update on post-exposure prophylaxis. Lancet Infect Dis. 2018 Jun;18(6):e183-e192. doi: 10.1016/S1473-3099(17)30677-1. Epub 2017 Nov 15. — View Citation
Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE; VRC 608 Study team. Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study. Lancet. 2019 Mar 2;393(10174):889-898. doi: 10.1016/S0140-6736(19)30036-4. Epub 2019 Jan 24. Erratum In: Lancet. 2020 May 30;395(10238):1694. — View Citation
Jacobs M, Aarons E, Bhagani S, Buchanan R, Cropley I, Hopkins S, Lester R, Martin D, Marshall N, Mepham S, Warren S, Rodger A. Post-exposure prophylaxis against Ebola virus disease with experimental antiviral agents: a case-series of health-care workers. Lancet Infect Dis. 2015 Nov;15(11):1300-4. doi: 10.1016/S1473-3099(15)00228-5. Epub 2015 Aug 25. — View Citation
Mbala-Kingebeni P, Aziza A, Di Paola N, Wiley MR, Makiala-Mandanda S, Caviness K, Pratt CB, Ladner JT, Kugelman JR, Prieto K, Chitty JA, Larson PA, Beitzel B, Ayouba A, Vidal N, Karhemere S, Diop M, Diagne MM, Faye M, Faye O, Aruna A, Nsio J, Mulangu F, Mukadi D, Mukadi P, Kombe J, Mulumba A, Villabona-Arenas CJ, Pukuta E, Gonzalez J, Bartlett ML, Sozhamannan S, Gross SM, Schroth GP, Tim R, Zhao JJ, Kuhn JH, Diallo B, Yao M, Fall IS, Ndjoloko B, Mossoko M, Lacroix A, Delaporte E, Sanchez-Lockhart M, Sall AA, Muyembe-Tamfum JJ, Peeters M, Palacios G, Ahuka-Mundeke S. Medical countermeasures during the 2018 Ebola virus disease outbreak in the North Kivu and Ituri Provinces of the Democratic Republic of the Congo: a rapid genomic assessment. Lancet Infect Dis. 2019 Jun;19(6):648-657. doi: 10.1016/S1473-3099(19)30118-5. Epub 2019 Apr 15. — View Citation
Misasi J, Gilman MS, Kanekiyo M, Gui M, Cagigi A, Mulangu S, Corti D, Ledgerwood JE, Lanzavecchia A, Cunningham J, Muyembe-Tamfun JJ, Baxa U, Graham BS, Xiang Y, Sullivan NJ, McLellan JS. Structural and molecular basis for Ebola virus neutralization by protective human antibodies. Science. 2016 Mar 18;351(6279):1343-6. doi: 10.1126/science.aad6117. Epub 2016 Feb 25. — View Citation
Moekotte AL, Huson MA, van der Ende AJ, Agnandji ST, Huizenga E, Goorhuis A, Grobusch MP. Monoclonal antibodies for the treatment of Ebola virus disease. Expert Opin Investig Drugs. 2016 Nov;25(11):1325-1335. doi: 10.1080/13543784.2016.1240785. Epub 2016 Oct 8. — View Citation
Sullivan N, Yang ZY, Nabel GJ. Ebola virus pathogenesis: implications for vaccines and therapies. J Virol. 2003 Sep;77(18):9733-7. doi: 10.1128/jvi.77.18.9733-9737.2003. No abstract available. — View Citation
* Note: There are 11 references in all — Click here to view all references
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05284097 -
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
|
Phase 2 | |
Completed |
NCT00072605 -
Experimental Ebola Vaccine Trial
|
Phase 1 | |
Completed |
NCT02911428 -
Open Study of the Duration of Immunity After Vaccination With GamEvac
|
N/A | |
Completed |
NCT02564523 -
Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults
|
Phase 2 | |
Completed |
NCT02283099 -
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVĪG-ZEBOV-GP)
|
Phase 1 | |
Terminated |
NCT02661464 -
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
|
Phase 3 | |
Recruiting |
NCT02967003 -
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
|
Phase 3 | |
Completed |
NCT02354404 -
Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda
|
Phase 1 | |
Completed |
NCT02342171 -
Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
|
Phase 2/Phase 3 | |
Completed |
NCT02598388 -
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
|
Phase 2 | |
Completed |
NCT02564575 -
Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults
|
Phase 1 | |
Completed |
NCT02378753 -
STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)
|
Phase 2/Phase 3 |