CIGB 2020 Phase I / II Clinical Trial to assess safety and immunogenicity of different routes and modes of administration in older adults. Randomized parallel group clinical trial.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 40 人开始时间: 2020年7月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Other

•1- Age greater than or equal to 60 years, both sexes.
•2- Personal history of HT, DM, cardiovascular diseases, kidney disease, cancer, osteoarthritis, atherosclerosis, obesity, chronic inflammatory disorders, autoimmune disorders, or any other that could constitute a risk factor for the competition of your innate immune system.
•3- Expression levels of at least one of the Toll-like receptors: TLR3, TLR7 and TLR8, lower than the GUS control.
•4- Voluntary nature of the patient to participate expressed through the delivery of signed informed consent.

•1- Expression levels of each of the Toll-like receptors (TLR3, TLR7 and TLR8), all above the GUS control.
•2- Diagnosis of SARS-CoV-2 infection within 14 days prior to recruitment.
•3- Acute illness at the time of recruitment, defined as the presence of a moderate or severe illness with or without fever.
•4- Axillary temperature = 38.0 ° C.
•5- History of tonsillectomy.
•6- Use of immunosuppressive drugs or chemotherapy at some point during the month prior to recruitment.
•7- Use of any investigational product (medicine or vaccine) within 30 days prior to recruitment, or that has been planned during the study period.
•8- Liver cirrhosis, hepatocellular carcinoma or a history of liver transplantation.
•9- History of allergy to any of the ingredients of the vaccine under study.
•10- Any problem that makes proper patient monitoring impossible.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana