{"id":"vpm1002","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (erythema, induration)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Lymphadenitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"VPM1002 is derived from the BCG vaccine but has been genetically modified to delete the ureC gene and insert the listeriolysin O (LLO) gene from Listeria monocytogenes. This modification enhances the vaccine's ability to trigger both CD4+ and CD8+ T-cell responses by improving antigen escape from the phagolysosome and promoting cross-presentation. The vaccine is designed to provide superior protection against tuberculosis compared to standard BCG.","oneSentence":"VPM1002 is a live attenuated recombinant tuberculosis vaccine that enhances immune response by expressing listeriolysin O to improve intracellular antigen presentation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:40:54.249Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis prevention in BCG-vaccinated and unvaccinated populations"},{"name":"Tuberculosis prevention in HIV-positive individuals"}]},"trialDetails":[{"nctId":"NCT05539989","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa","status":"WITHDRAWN","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2025-12-31","conditions":"Tuberculosis, HIV Infections","enrollment":""},{"nctId":"NCT03152903","phase":"PHASE2, PHASE3","title":"Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2017-12-15","conditions":"Prevention of TB Recurrence","enrollment":2000},{"nctId":"NCT04351685","phase":"PHASE3","title":"Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2020-11-09","conditions":"Mycobacterium Tuberculosis Infection","enrollment":6940},{"nctId":"NCT02371447","phase":"PHASE1, PHASE2","title":"VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer","status":"COMPLETED","sponsor":"Swiss Cancer Institute","startDate":"2015-09-08","conditions":"Bladder Cancer","enrollment":39},{"nctId":"NCT04439045","phase":"PHASE3","title":"Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2020-06-24","conditions":"SARS-CoV-2 Infection","enrollment":122},{"nctId":"NCT04435379","phase":"PHASE3","title":"Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic","status":"COMPLETED","sponsor":"Serum Life Science Europe GmbH","startDate":"2020-06-18","conditions":"Infection, Respiratory Tract","enrollment":2038},{"nctId":"NCT04387409","phase":"PHASE3","title":"Study to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 Pandemic","status":"UNKNOWN","sponsor":"Serum Life Science Europe GmbH","startDate":"2020-05-25","conditions":"Infection, Respiratory Tract","enrollment":59},{"nctId":"NCT02391415","phase":"PHASE2","title":"Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2015-06","conditions":"Tuberculosis","enrollment":416},{"nctId":"NCT01479972","phase":"PHASE2","title":"Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa","status":"COMPLETED","sponsor":"Serum Life Science Europe GmbH","startDate":"2011-11","conditions":"Tuberculosis","enrollment":48},{"nctId":"NCT01113281","phase":"PHASE1","title":"Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison to BCG in Healthy Volunteers in South Africa","status":"COMPLETED","sponsor":"Serum Life Science Europe GmbH","startDate":"2010-04","conditions":"Tuberculosis","enrollment":24},{"nctId":"NCT00749034","phase":"PHASE1","title":"Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Serum Life Science Europe GmbH","startDate":"2008-09","conditions":"Tuberculosis, Healthy","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["recombinant BCG for TB","Mycobacterium bovis rBCGΔureC::hly"],"phase":"phase_3","status":"active","brandName":"VPM1002","genericName":"VPM1002","companyName":"Serum Life Science Europe GmbH","companyId":"serum-life-science-europe-gmbh","modality":"Biologic","firstApprovalDate":"","aiSummary":"VPM1002 is a live attenuated recombinant tuberculosis vaccine that enhances immune response by expressing listeriolysin O to improve intracellular antigen presentation. Used for Tuberculosis prevention in BCG-vaccinated and unvaccinated populations, Tuberculosis prevention in HIV-positive individuals.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}