{"id":"recombinant-mycobacterium-tuberculosis-fusion-protein","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, erythema, induration)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"The fusion protein is engineered to present conserved TB antigens in a single immunogenic construct, designed to enhance T-cell and B-cell recognition of Mycobacterium tuberculosis. By combining multiple epitopes, it aims to broaden immune coverage and improve protection against active TB disease and/or latent TB infection reactivation.","oneSentence":"This recombinant fusion protein combines multiple Mycobacterium tuberculosis antigens to stimulate cellular and humoral immune responses against tuberculosis infection.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:31:45.348Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (active disease or latent TB infection prevention)"}]},"trialDetails":[{"nctId":"NCT06062238","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gates Medical Research Institute","startDate":"2024-03-05","conditions":"Tuberculosis","enrollment":20080},{"nctId":"NCT07152639","phase":"PHASE3","title":"Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above","status":"RECRUITING","sponsor":"Chengdu CoenBiotech Co., Ltd","startDate":"2025-08-09","conditions":"Tuberculosis","enrollment":1784},{"nctId":"NCT04556981","phase":"PHASE2","title":"Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV","status":"COMPLETED","sponsor":"Gates Medical Research Institute","startDate":"2020-11-17","conditions":"Human Immunodeficiency Virus","enrollment":402},{"nctId":"NCT05899179","phase":"PHASE3","title":"Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above","status":"RECRUITING","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2023-08-03","conditions":"Latent Tuberculosis Infection","enrollment":780},{"nctId":"NCT05746611","phase":"PHASE4","title":"Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein","status":"COMPLETED","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2023-04-17","conditions":"Latent Tuberculosis Infection","enrollment":7500},{"nctId":"NCT06224608","phase":"PHASE1","title":"Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Chengdu CoenBiotech Co., Ltd","startDate":"2023-01-17","conditions":"Tuberculosis","enrollment":60},{"nctId":"NCT05284812","phase":"PHASE2","title":"A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)","status":"SUSPENDED","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2022-02-10","conditions":"Tuberculosis","enrollment":200},{"nctId":"NCT01999231","phase":"PHASE1","title":"Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10","status":"COMPLETED","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2013-09","conditions":"Healthy","enrollment":32},{"nctId":"NCT02375256","phase":"PHASE1","title":"A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402","status":"COMPLETED","sponsor":"Aeras","startDate":"2009-10","conditions":"Tuberculosis","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["EC"],"phase":"phase_3","status":"active","brandName":"Recombinant Mycobacterium Tuberculosis Fusion Protein","genericName":"Recombinant Mycobacterium Tuberculosis Fusion Protein","companyName":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","companyId":"anhui-zhifei-longcom-biologic-pharmacy-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"This recombinant fusion protein combines multiple Mycobacterium tuberculosis antigens to stimulate cellular and humoral immune responses against tuberculosis infection. Used for Tuberculosis (active disease or latent TB infection prevention).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}