Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis - An Interventional Study

Institute of Liver and Biliary Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•The following patients will be enrolled in the study under Group 1:
•1) Evidence of liver cirrhosis established during the clinical investigations and/or hospital stay, as evidenced by clinical, endoscopic, radiological and/or histological criteria.
•2) Baseline Negative SARS-COV19 IgG neutralizing antibodies.
•The following patients (healthy controls) will be enrolled in the study:
•1) Baseline Negative SARS-COV19 IgG neutralizing antibodies
•2) No previous COVID-19 infection
•3) No major respiratory, cardiac comorbid illnesses or malignancy or immunosuppressed state

•1.Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
•2.Prior or concomitant vaccine therapy for COVID-19
•3.ICU patients
•4.Hemodynamically unstable patients, shock
•5.Significant encephalopathy, acute kidney injury
•6.Documented or suspected sepsis including chest infection
•7.ACLF (Acute on Chronic Liver Failure)
•8.Significant cardiac or respiratory co-morbidities
•9.Known allergy to vaccination
•10.Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
•11.History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 (Covishield) vaccine.
•12.Any history of angioedema.
•13.Any history of anaphylaxis.
•14.Pregnancy, lactation or willingness/intention to become pregnant during the study.
•15.Any other serious chronic illness requiring hospital specialist supervision.
•16.Currently or in last 3 weeks have: fever/cough/sorethroat/rhinorrhea/hemoptysis/breathlessness/chest pain/myalgia/nausea/vomiting/diarrhea/abdominal pain/loss of taste.

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