Havana, Cuba: From the beginning of the pandemic words such as isolation, curves and masks accompany us daily, now in the face of phase III of the Cuban anti-Covid-19 Sovereign 02 vaccine candidate, other terms are added to our daily life today, Prensa Latina publishes.
Multicenter, adaptive, double-blind and placebo-controlled are concepts inherent in this new period, the closest, if the results show it, to achieving immunization against the SARS-Cov-2 virus, which causes the disease.
In the case of Soberana 02, the research involves several scientific institutions and will have as allies different entities of the health system at all levels, which is why it is multicenter.
The trial will be carried out in eight Havana municipalities and will be adaptive, since it will have several evaluations at different times to determine if there are differences between the individuals immunized with the new formulation and those who are administered a placebo, a compound devoid of active principle.
In fact, the study will be characterized by being placebo-controlled, lacking the RBD (receptor-binding domain), the virus antigen, while two other vaccination schedules are planned with the molecule studied.
The 44 thousand 10 volunteers included in the capital, from 19 to 80 years of age, will not know which of the formulations designed in the inoculation schemes they will receive at any of the moments, neither will the administrators nor the evaluators, as stipulated by the clinical trial methodologies.
For the developers of this candidate, the Finlay Vaccine Institute and the regulatory authorities, the objective of the study is to evaluate the efficacy of the product, but also to prevent people from suffering from a symptomatic disease caused by SARS-Cov-2 and, in turn, prevent the infection.
In the researchers’ opinion, these are variables that need to be demonstrated: the future vaccine must be effective in preventing disease and infection.
In a month they aspire to apply the first dose to the volunteers, for which 30 clinical sites and 48 are conditioned for the application of the product.
