{"id":"recombinant-subunit-herpes-zoster-vaccine","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Injection site pain"},{"rate":"35-45","effect":"Injection site erythema"},{"rate":"20-30","effect":"Injection site swelling"},{"rate":"30-40","effect":"Myalgia"},{"rate":"25-35","effect":"Fatigue"},{"rate":"20-30","effect":"Headache"},{"rate":"10-15","effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL4297975","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant varicella-zoster virus (VZV) glycoprotein E (gE) combined with an adjuvant system (AS01B) that enhances immune response. This approach triggers both cellular and humoral immunity against VZV without the risks associated with live attenuated vaccines, providing durable protection against herpes zoster and post-herpetic neuralgia in older adults and immunocompromised populations.","oneSentence":"A recombinant subunit vaccine that stimulates the immune system to recognize and prevent herpes zoster (shingles) infection by presenting viral antigens without live virus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:04:20.714Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of herpes zoster (shingles) in adults aged 50 years and older"},{"name":"Prevention of herpes zoster in immunocompromised adults"}]},"trialDetails":[{"nctId":"NCT05811754","phase":"","title":"Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2022-05-09","conditions":"Herpes Zoster","enrollment":2844},{"nctId":"NCT03798691","phase":"PHASE4","title":"Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2019-05-28","conditions":"Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis","enrollment":33},{"nctId":"NCT05966090","phase":"PHASE3","title":"A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-07-28","conditions":"Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections","enrollment":530},{"nctId":"NCT04748939","phase":"PHASE4","title":"Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT","status":"NOT_YET_RECRUITING","sponsor":"Tuen Mun Hospital","startDate":"2025-01","conditions":"Herpes Zoster","enrollment":140},{"nctId":"NCT03993717","phase":"","title":"Solid Organ Transplant SHINGRIX","status":"TERMINATED","sponsor":"Emory University","startDate":"2020-01-30","conditions":"Kidney Transplant; Complications","enrollment":2},{"nctId":"NCT05371080","phase":"PHASE3","title":"A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2022-08-10","conditions":"Herpes Zoster","enrollment":3038},{"nctId":"NCT04523246","phase":"EARLY_PHASE1","title":"Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents","status":"COMPLETED","sponsor":"University of Oklahoma","startDate":"2020-09-01","conditions":"Herpes Zoster, Allergy and Immunology, Corona Virus Infection","enrollment":217},{"nctId":"NCT05047770","phase":"PHASE3","title":"A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-10-07","conditions":"Herpes Zoster","enrollment":2013},{"nctId":"NCT03493776","phase":"PHASE4","title":"Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation","status":"UNKNOWN","sponsor":"Deepali Kumar","startDate":"2018-04-15","conditions":"Varicella Zoster Vaccine","enrollment":50},{"nctId":"NCT03685682","phase":"PHASE3","title":"Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2018-05-25","conditions":"Varicella Zoster Vaccine","enrollment":23},{"nctId":"NCT00474526","phase":"PHASE3","title":"A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants","status":"COMPLETED","sponsor":"Novartis Vaccines","startDate":"2007-03","conditions":"Meningitis, Meningococcal","enrollment":4545}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Shingrix"],"phase":"marketed","status":"active","brandName":"recombinant subunit Herpes zoster vaccine","genericName":"recombinant subunit Herpes zoster vaccine","companyName":"University Health Network, Toronto","companyId":"university-health-network-toronto","modality":"Biologic","firstApprovalDate":"","aiSummary":"A recombinant subunit vaccine that stimulates the immune system to recognize and prevent herpes zoster (shingles) infection by presenting viral antigens without live virus. Used for Prevention of herpes zoster (shingles) in adults aged 50 years and older, Prevention of herpes zoster in immunocompromised adults.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}