Assessment of the effect and safety of CIGB2020 in asymptomatic subjects = 60 years old, contacts of patients diagnosed of acute respiratory infections (ARI), as compared to a control group from the same population (COVID-19) - PROFIRA

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 1,440 人开始时间: 2021年3月11日最近更新: 2024年8月19日

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: No intervention. Assignment: Parallel. Purpose: Prevention

•1. Adults = 60 years old, both sexes.
•2. All subjects = 60 years old, contacts of patients diagnosed with flu, cold, dengue fever, SARS-CoV2 or other acute respiratory infections to be randomized during the study.
•3. Subjects having agreed their informed consent to participate in the study.

•1. Diagnostic of SARS-CoV-2 infection since the day 14th previous to recruitment.
•2. Use of immunosuppressor drugs during one month previous to recruitment.
•3. Liver cirrhosis by HBV or liver transplant due to HBV.
•4. Any problem avoiding the addequate follow-up of the contact older than sixty.
•5. Terminal disease at the moment of recruitment.
•6. History of allergy to some of the ingredients of the vaccine under study
•7. Pregnancy or lactancy

发起方

Center for Genetic Engineering and Biotechnology (CIGB)