HAVANA, Cuba, Jan 25 (ACN) Based on a Phase I clinical study being carried out at the Institute of Hematology and Immunology in Havana, researchers from the Finlay Vaccine Institute are assessing the safety and immunogenicity of the candidate Soberana 01 in patients convalescing from COVID-19 with low levels of neutralizing antibodies.
A group of 30 Cuban volunteers, between the ages of 19 and 59, began the study last January 16 and on Saturday they attended the seventh day consultation, where samples were taken to determine their immune response, with no serious adverse events reported, Dr. Arturo Chang Monteagudo, 1st and 2nd degree specialist in Immunology and principal investigator of the clinical trial, told the press.
At the same time, Rolando Ochoa Azze, PhD in Medical Sciences, specialist of 1st and 2nd Degree in Immunology of the Finlay Vaccine Institute, explained that this study is the only one done in the world aimed at this population group, as they are individuals with relatively low SARS-CoV-2 inhibition percentages, that is, who have not had sufficient immunity and can be re-infected.
He detailed that the hypothesis considered by the specialists is that the people in contact with the virus "must have memory B cells against the spike protein, and therefore we intend to stimulate these cell clones with the vaccine candidate Soberana 01".
Regarding how the study is carried out, the principal investigator of the clinical trial indicated that the volunteers were divided into three groups: asymptomatic, mildly symptomatic and positive to antibody studies, among them were included people with compensated chronic pathologies, a characteristic that distinguishes the studies with the Soberana vaccine candidate.
Chang Monteagudo pointed out that the investigations last for 28 days, from the application of the single dose until the last evaluation, and specified that since January 9, a prior consultation of the volunteers was carried out to determine their inclusion.
These people are followed up during the three hours after the administration of the product and follow-up consultations are carried out 24, 48 and 72 hours later and then on the seventh day, the 14th and the 28th.
It is a single dose because the scientific premise is that all those involved have already had the disease and the application of the drug is a reinforcement of the individual's immunity, the expert continued.
For the Soberana 01 vaccine candidate, five different formulations were developed, two of which completed their clinical studies in December 2020, and all of them have shown safety and immunogenicity, Chang Monteagudo concluded.
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