The first enrollment of subjects is scheduled for August 24.
August 18 (teleSUR) Cuba advances in the development of its COVID-19 vaccine as the country already has four vaccine candidates and one of them has already been approved for clinical trials.
The Finlay Vaccine Institute (IFV) registered a clinical trial for one of its vaccine candidates on August 13 in the Cuban Public Registry of Clinical Trials. The trial, named SOBERANA 01, is on phase I and II and the first enrollment of subjects is expected on August 24.
According to the Cuban Public Registry of Clinical Trials, these phases include “randomized, controlled, adaptive, double-blind, and multicenter study to evaluate the safety, reactogenicity, and immunogenicity, of the prophylactic FINLAY-FR-1 anti-SARS-CoV-2 Vaccine Candidate in a two-doses schedule.
During phase I the vaccine candidate FINLAY-FR-1 is expected to be safe, admitting no more than 5% of individuals with serious adverse events while during phase II The proportion of subjects with an immune response is expected to be at least 50% higher than the control group.
The vaccine candidate FINLAY-FR-1 will be administered to subjects aged between 19-59 and individuals between 60 to 80 years old as well as women of childbearing potential using safe contraceptive methods during the study.
According to the information published in the Cuban Public Registry of Clinical Trials, the two first clinical sites to participate in the study are located in Havana.
The clinical trial is expected to be completed on January 11, 2021, and the first data will be published on February 15, 2021.