{"id":"mycobacterium-vaccae-for-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (erythema, induration, pain)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108760","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains heat-inactivated Mycobacterium vaccae, a non-pathogenic mycobacterium that primes dendritic cells and T cells to shift the immune response toward a Th1 phenotype, enhancing cell-mediated immunity. This approach is designed to boost protective immune responses in patients with tuberculosis or to provide adjunctive immunotherapy in combination with standard anti-TB drugs. The mechanism relies on pattern recognition receptors and mycobacterial antigens to activate innate and adaptive immunity.","oneSentence":"Mycobacterium vaccae is an inactivated whole-cell vaccine that stimulates the immune system to enhance Th1-mediated cellular immunity against tuberculosis and other mycobacterial infections.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:56:17.257Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (adjunctive immunotherapy in combination with standard anti-TB chemotherapy)"},{"name":"Mycobacterial infections"}]},"trialDetails":[{"nctId":"NCT05680415","phase":"PHASE4","title":"Clinical Trial of Mica","status":"ACTIVE_NOT_RECRUITING","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2023-04-19","conditions":"Latent Tuberculosis Infection","enrollment":6800},{"nctId":"NCT01979900","phase":"PHASE3","title":"Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis","status":"COMPLETED","sponsor":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","startDate":"2013-10","conditions":"Tuberculosis","enrollment":10000}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Mycobacterium Vaccae for Injection","genericName":"Mycobacterium Vaccae for Injection","companyName":"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.","companyId":"anhui-zhifei-longcom-biologic-pharmacy-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"Mycobacterium vaccae is an inactivated whole-cell vaccine that stimulates immune responses to enhance anti-tuberculosis immunity and potentially modulate Th1/Th2 balance. Used for Tuberculosis (adjunctive immunotherapy in combination with standard anti-TB chemotherapy), Pulmonary tuberculosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}