{"id":"spikogen-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or swelling"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SpikoGen uses recombinant spike protein technology to train the immune system to recognize and respond to SARS-CoV-2. The vaccine aims to generate both antibody and T-cell mediated immunity against the viral spike protein, which is the primary target for neutralizing antibodies. This approach differs from mRNA and viral vector vaccines by using a directly manufactured protein antigen.","oneSentence":"SpikoGen is a recombinant protein vaccine designed to stimulate immune responses against SARS-CoV-2 spike protein.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:35:54.374Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"COVID-19 prevention (SARS-CoV-2 infection)"}]},"trialDetails":[{"nctId":"NCT06355232","phase":"PHASE1","title":"Covid-19 and Influenza Oral Vaccine Study","status":"RECRUITING","sponsor":"Vaxine Pty Ltd","startDate":"2024-05-01","conditions":"covid19 Infection, Influenza, Human","enrollment":100},{"nctId":"NCT05279456","phase":"PHASE3","title":"A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)","status":"COMPLETED","sponsor":"Vaxine Pty Ltd","startDate":"2022-08-15","conditions":"COVID-19","enrollment":39},{"nctId":"NCT05542862","phase":"PHASE3","title":"Booster Study of SpikoGen COVID-19 Vaccine","status":"COMPLETED","sponsor":"Vaxine Pty Ltd","startDate":"2022-09-07","conditions":"COVID-19","enrollment":81},{"nctId":"NCT05148871","phase":"PHASE2, PHASE3","title":"Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vaxine Pty Ltd","startDate":"2022-03-01","conditions":"COVID-19","enrollment":200},{"nctId":"NCT05285384","phase":"NA","title":"Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2022-02-04","conditions":"COVID-19","enrollment":43},{"nctId":"NCT05231590","phase":"PHASE3","title":"Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2022-02-23","conditions":"COVID-19","enrollment":581},{"nctId":"NCT05175625","phase":"PHASE3","title":"Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2021-12-15","conditions":"COVID-19","enrollment":300},{"nctId":"NCT05005559","phase":"PHASE3","title":"Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2021-08-07","conditions":"Covid19","enrollment":16876},{"nctId":"NCT04944368","phase":"PHASE2","title":"Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2021-05-30","conditions":"Covid19","enrollment":400}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Covax-19"],"phase":"phase_3","status":"active","brandName":"SpikoGen vaccine","genericName":"SpikoGen vaccine","companyName":"Vaxine Pty Ltd","companyId":"vaxine-pty-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"SpikoGen is a recombinant protein vaccine designed to stimulate immune responses against SARS-CoV-2 spike protein. Used for COVID-19 prevention (SARS-CoV-2 infection).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}