The clinical trial of the vaccine candidate SOBERANA 01 against COVID-19, the first in Latin America, began on Monday, with the shot to 20 volunteers aged 19 to 59, at the National Center of Toxicology, in western Havana.
This way, the trial fulfills its first stage, reported since it was announced that Cuba entered the select group of 14 countries with vaccination candidates against COVID-19 that had succeeded in advancing towards clinical trials.
The Cuban Public Registry of Clinical Trials defines SOBERANA 01 as a randomized, controlled, adaptive and multicenter study, to assess the candidate’s safety, reactivity and immunogenicity in a two-dose scheme.
After being tested on such volunteers, the study reported zero serious adverse events, Dagmar Garcia Rivera, director of research at the Finlay Vaccine Institute, leader of the study, posted on Twitter.
It is expected that for the first stage of the trial, the vaccine will be administered safely, with no more than 5% of individuals with serious adverse events. In the second stage, the proportion of subjects with an immune response is expected to be at least 50% higher than in the control group.
The study should be completed by January 11, 2021, and the results would be ready by February 1, for publication on February 15.