Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial for the evaluation in adults of the efficacy, safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 48,290 人开始时间: 2021年3月18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: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Prevention

•1) Subjects with a history of SARS-CoV-2 infection confirmed by RT-PCR or with this virological diagnosis at the time of inclusion in the study.
•2) Convalescent, contact or suspect of COVID-19 at the time of inclusion.
•3) Subjects who have received a vaccine candidate against COVID-19.
•4) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia.
•5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.
•6) Body mass index =18 or = 35 Kg / m2.
•7) Subjects with tattoos in both deltoid regions.
•8) Administration of any research product in the last three months.
•9) Subject treated in the last three months or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study.
•10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study.
•11) Known hypersensitivity to thiomersal and to any of the components of the formulation under study.
•12) History or suspicion of alcoholism or drug dependence.
•13) Pregnancy or breastfeeding. Woman of reproductive age not using contraceptives or planning pregnancy.
•14) Obvious mental incapacity to issue consent and act accordingly with the study.

发起方

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