The second phase of the Soberana Plus clinical trial will cover 450 individuals, as well as expanding the inclusion criteria compared to Phase I, as explained by Rolando Ochoa Azze, researcher and professor of the Finlay Vaccine Institute (IFV), the entity that is developing this COVID-19 vaccine.
In a television appearance broadcast this Monday, Ochoa Azze explained that the process will incorporate those who suffered the disease in a mild way, the asymptomatic and those recovered after moderately suffering it, the Agencia Cubana de Noticias news agency reported.
The new phase comprises an age range that groups subjects between 19 and 80 years old, and those who classify with obesity grade I will be able to participate.
The specialist pointed out that they will continue to include people with chronic conditions, no matter what they are, as long as they are compensated at the time of recruitment and, like the rest, that two months or more have elapsed since their hospital discharge, as a guarantee of their complete recovery.
He also said that a small group of volunteers will be given a placebo, but once the study is over, they will all receive Soberana Plus. As only one dose is required, completion is expected in 28 days.
Ochoa Azze insisted that this stage comes after having successfully concluded the first phase, in which positive indicators of the candidate were demonstrated, with the induction of high levels of neutralizing antibodies against the virus and the ability to protect from reinfection, the ACN indicated.
He also commented that the rate of adverse events was much lower than those reported in international studies, since they were practically limited to pain at the site of inoculation and redness in the area in some cases.
¿Por qué #SoberanaPlus?. Se sabe que las personas que han tenido la #COVID19, pueden sufrir de re-infección. En #Cuba tendremos un cifra importante de convalescientes que son necesarios proteger. Por otra parte, la #SoberanaPlus puede ser una #Vacuna de refuerzo ante nuevas cepas pic.twitter.com/korZMwaNia
— Instituto Finlay de Vacunas (@FinlayInstituto) April 12, 2021
Less than 20 percent of those vaccinated had some type of adverse reaction, none serious, and no severe events were detected, said the doctor cited by the source, which underlines the non-inclusion in the trial of those who suffered severe or critical COVID-19, because they have higher neutralizing antibody titers, and also for their own safety, since their health was very delicate.
However, he said that when the studies advance, the possibility of adding other population groups will be evaluated. Soberana Plus is also ideal as a booster dose for Soberana 01 and 02, the specialist stressed.
The trial will be carried out mainly at the Institute of Hematology and Immunology and will evaluate the protective immune response of the product, its safety and reactogenicity.