Phase II clinical trial of Soberana Plus to enroll 450 convalescents
CN) The Phase II clinical trial of Soberana Plus in convalescents will include 450 individuals and will broaden the inclusion criteria compared to Phase I, informed today an expert from the Finlay Vaccine Institute (IFV), the entity that developed this vaccine candidate against COVID-19.
Rolando Ochoa Azze, Researcher and Professor of that institution, explained in a television appearance that the process will include those who had the disease with a mild clinical picture and those who are asymptomatic, as well as those who recovered after suffering from the new coronavirus in a moderate way.
Likewise, he said, it will include a wider age range, in subjects from 19 to 80 years of age, and those with grade I obesity will be able to participate.
He 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 as long as two months or more have elapsed since their discharge from the hospital, as a guarantee of their complete recovery.
The specialist added that the trial will be carried out mainly at the Institute of Hematology and Immunology and will evaluate the product’s protective immune response, its safety and reactogenicity.
He detailed that placebo will be applied to a small group of those recruited, but once the study is over, all will receive Soberana Plus, and since only one dose is required, it is expected to be completed after 28 days.
Read here: Phase II clinical trial of Cuban anti-COVID-19 Soberana Plus vaccine candidate approved to begin.
Ochoa Azze insisted that this stage comes after the satisfactory conclusion of 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 capacity to protect against reinfection.
He also commented that the rate of adverse events was much lower than those reported in international studies, as they were practically limited to pain at the inoculation site and redness in the area in some cases.
Less than 20 percent of those vaccinated had some kind of adverse reaction, none of them serious, and no severe events were detected, the doctor pointed out.
He explained that those who suffered a severe or critical COVID-19 are not yet included, because they have higher neutralizing antibody titers, and also for their own safety, since their health was very delicate.
However, he said that as the studies progress, the possibility of adding other population groups will be assessed.
The researcher clarified that re-infection with SARS-CoV-2 has been reported in the world in individuals with low levels of neutralizing antibodies, especially as a result of the emergence of new strains and, therefore, this vaccination is necessary to protect convalescents, almost 90 thousand in Cuba.
He pointed out that Soberana Plus is used and not another vaccine candidate, because it is able to act directly on the memory B cells and activate them to produce antibodies, and its reactivity is considerably lower due to its formulation.
According to these characteristics, Ochoa Azze added, this drug is also suitable as a booster dose for Sovereign 01 and 02, hence its name, which gives the idea of adding, deepening, perfecting and broadening a response.
The professor ended his speech by emphasizing that we must all take care of ourselves, including those who receive Sovereign Plus, since in the case of COVID-19 it will be necessary to vaccinate around 80 or 90 percent of the population to be able to speak of herd immunity, and that will only be possible with mass vaccination.
Soberana Plus is based on recombinant proteins from the virus region that bind to the receptor on human cells, and two molecules of this protein are coupled to increase immunogenicity.