Phase II clinical trial of vaccine candidate Soberana Plus to include 450 COVID 19 convalescents
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The Phase II clinical trials of Soberana Plus in convalescents of COVID 19 will include 450 people 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 at that institution, explained in a TV presentation that the process will include those who had the disease with a mild clinical condition and asymptomatic people, as well as those who have recovered after suffering from the novel coronavirus in a moderate way.
Also, he said, it will include an older age range, in the 19 to 80 years old age group, and those with grade I obesity will be allowed to participate.
The expert pointed out that they will continue including people with chronic conditions, no matter what they are, as long as they are compensated at the time of registration, and as long as two months or more have been passed 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 assess the product's protective immune response, its safety and reactogenicity.
Ochoa Azze explained that a placebo will be applied to a small group of those enrolled, but once the study is completed, all will receive Soberana Plus, and since only one dose is required, it is expected to be completed after 28 days.
The scientist insisted that this stage comes after the satisfactory conclusion of the first phase, which showed positive indicators for the candidate, 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, since they were practically limited to pain at the inoculation site and reddening in the area in some cases.
The researcher 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 when the studies advance, the possibility of adding other population groups will be assessed.
Ochoa Azze stressed that Soberana Plus is used and not any other vaccine candidate, because it is capable of acting directly on the memory B cells and activating them to produce antibodies, and its reactivity is considerably lower due to its formulation.
The professor ended his speech by emphasizing that we must all take care of ourselves, including those who receive Soberana Plus, because in the case of COVID-19 it will be necessary to vaccinate around 80 or 90 % of the population to be able to speak of herd immunity, and this will only be possible with mass vaccination.
