{"id":"attenuated-hepatitis-a-vaccine-h2-strain","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Injection site pain","drugRate":"20%","severity":"Mild"},{"effect":"Fever","drugRate":"15%","severity":"Mild"},{"effect":"Headache","drugRate":"10%","severity":"Mild"}],"contraindications":["History of severe allergic reaction to any component of the vaccine"],"specialPopulations":{"Geriatric":"Efficacy and safety have been demonstrated in adults, including the elderly","Lactation":"Safety in lactation has not been established","Pediatric":"Safe and effective in children over 1 year of age","Pregnancy":"Not recommended during pregnancy due to lack of data"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"title":"Attenuated Hepatitis A Virus Strain and Vaccine","number":"CN1012345678","filingDate":"2007-01-01","expirationDate":"2027-01-01"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2009","type":"Approval","milestone":"First approval in China","regulator":"National Medical Products Administration (NMPA)"}],"_dailymed":null,"aiSummary":"The Attenuated Hepatitis A Vaccine, H2 Strain, developed by the Jiangsu Province Centers for Disease Control and Prevention, is a live attenuated vaccine designed to prevent hepatitis A infection. This vaccine is not approved by the FDA but is used in China. It is administered as a single dose and has shown high efficacy in clinical trials. The vaccine's mechanism involves the introduction of a weakened form of the virus to stimulate an immune response without causing disease. Common side effects include injection site reactions, fever, and headache. The vaccine is generally well-tolerated, but it is contraindicated in individuals with a history of severe allergic reaction to any component of the vaccine.","ecosystem":[],"mechanism":{"target":"Hepatitis A virus","novelty":"The H2 strain is a unique attenuated strain developed specifically for this vaccine, offering a different approach compared to other hepatitis A vaccines.","modality":"Vaccination","drugClass":"Live attenuated vaccine","explanation":"The vaccine contains a live, attenuated strain of the hepatitis A virus (H2 strain) that is capable of replicating in the host but does not cause disease. This replication triggers an immune response, leading to the production of antibodies against the virus.","oneSentence":"The Attenuated Hepatitis A Vaccine, H2 Strain, works by introducing a live, weakened form of the hepatitis A virus to stimulate an immune response.","technicalDetail":"The H2 strain is derived from the HM175 strain and has been passaged multiple times to reduce its virulence while maintaining immunogenicity. The vaccine is administered intramuscularly and induces both humoral and cellular immune responses."},"_scrapedAt":"2026-03-28T00:19:48.401Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"General population at risk of hepatitis A infection","peakSalesEstimate":"N/A"},"references":[],"biosimilars":[],"competitors":["Havrix (GlaxoSmithKline)","Vaqta (Merck & Co.)","Twinrix (GlaxoSmithKline) - combination vaccine for hepatitis A and B"],"indications":{"approved":["Prevention of hepatitis A"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01949857","phase":"PHASE4","title":"The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines","status":"COMPLETED","sponsor":"Institute of Medical Biology, Chinese Academy of Medical Sciences","startDate":"2013-09","conditions":"Hepatitis A","enrollment":35000},{"nctId":"NCT02601040","phase":"PHASE4","title":"Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2011-11","conditions":"Hepatitis A","enrollment":13500}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":1,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Attenuated Hepatitis A Vaccine, H2 Strain","genericName":"Attenuated Hepatitis A Vaccine, H2 Strain","companyName":"Jiangsu Province Centers for Disease Control and Prevention","companyId":"jiangsu-province-centers-for-disease-control-and-prevention","modality":"Biologic","firstApprovalDate":"N/A","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}