Although sights are set on the Cuban vaccine candidates Soberana 02 and Abdala (CIGB-66), who began Phase III of clinical trials this month, the favorable results in the tests with Soberana 01B will allow to extend this method in a second phase to a greater number of patients affected by the virus, complying with the regulatory requirements for this kind of study.
About this issue, doctor Consuelo Macias told Prensa Latina about the conclusions of the clinical trial with Soberana 01B, from the Finlay Vaccine Institute (IFV), which is making progress at the Institute of Hematology and Immunology (IHI), the clinical site of the research and the center she have been directing for eight years.
Macias pointed out that the expected immunogenicity was proved, as it achieved to raise the anti-SARS-CoV-2 antibody titer and the percentage inhibition effect of the binding of the virus to the cell to the expected values, proving safety without evidence of serious adverse events.
From its design, she pointed out, the objective was to protect those patients recovered from the disease through immunization. Hence, to achieve a better level of immunity, they received a single booster shot.
The doctor commented that ‘the idea arises because in trials and clinical researches, such as the treatment with convalescent plasma for Covid-19 patients and stem cells recovered from lung injuries at the IHI, the evidence that the asymptomatic or mild symptomatic patients had a lower anti-SARS CoV-2 antibody response was observed.’
Regarding the exploratory test of the validity of the procedure with autologous stem cells in the convalescent patient with lung injury, the specialist highlighted that the progress has been satisfactory and no adverse reactions are found.
With important achievements in the field of Hematology, the IHI undertook several investigations related to Covid-19 practically since the first cases were detected in Cuba a year ago.