Soberana 01: the novelty of a trial with Covid-19 patients

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Although the hopes of Cuban science to triumph against Covid-19 seem to be centered on the remarkable progress in the studies of the vaccine candidate Soberana 02, the truth is that the research to demonstrate the safety and immunogenicity of the possible Soberana 01 vaccine is also taking firm steps.

Dr. Rolando Ochoa Azze, head researcher of the Finlay Vaccine Institute, developer of both candidates, explained that, after the analysis of the five formulations belonging to the Soberana 01 family was concluded in December 2020, its less complex and safer variant is being tested in a clinical trial since January 16.

He argued that the vaccination was performed in disease patients, who have low levels of neutralizing antibodies and, therefore, may be susceptible to re-infection.

The 30 volunteers (between 19 and 59 years of age) selected for the test, whose clinical site is at the Institute of Hematology and Immunology, in Havana, had a mild clinical picture or were asymptomatic, and were positive to the antibody studies.

Soberana 01 trials include Covid-19 patients

Dr. Arturo Chang Monteagudo, principal investigator of the study, which lasts 28 days, explained that, although the conventional practice in phase I trials is to choose healthy and young people, the difference with this one is that, by working with a population that has already been in contact with the virus, it was possible to include volunteers with some chronic pathology, but who are compensated.

A second premise is related to the inhibition percentages of antibodies against SARS-COV-2 being relatively low, that is, that the person has not become immune to the virus. “The most important thing is to protect this sector of the population that, although they have been infected, can be re-infected and develop the disease. For that reason, this trial is a novelty worldwide, since research has been focused on the population sector that has not been infected,” he said.

Cuba presented the progress of Soberana 01 to WHO and PAHO.

He reported that there are no serious adverse events, and he explained that administering the vaccine only once is due to the fact that the volunteers have already been vaccinated naturally because they have been in contact with the virus. Therefore, the single dose functions as a booster to the individual’s immunity.

(Taken from Granma)

 

Radio Grito de Baire

Webmaster Jorge Luis Lora Moran Digital Edition Radio Grito de Baire, Contramaestre, Cuba.

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