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The Center for Genetic Engineering and Biotechnology (CIGB) reported that the anti-COVID-19 vaccine candidate Mambisa is now on the global list of nasal immunogens advancing to the clinical trial phase.
Gerardo Guillén, Director of Biomedical Research at CIGB, explained that there are more than 300 immunogens in the world, but only five are administered in this way.
The Antillean scientist assured that it has been demonstrated that a single dose in convalescents is enough to stimulate the response reached to a level of antibodies equal to or higher than that of people who were not in contact with the SARS-CoV-2 virus, which causes COVID-19.
Cuba's Center for State Control of Medicines, Equipment and Medical Devices approved last July 13 the phase I/II clinical trial to evaluate the safety and immunogenicity of the intranasal vaccine candidate Mambisa.
According to information from the Cuban Public Registry of Clinical Trials, there will be 120 volunteers, between 19 and 80 years of age, and at least two months after having been discharged from the hospital.
It was reported that the setting will be the Hermanos Ameijeiras Clinical Surgical Hospital, in Havana, and the first stage includes four groups, where the immunogenicity and functionality of the administration by nasal spray and nasal drops of the vaccine candidate Mambisa will be analyzed.
Another objective is to identify, according to the benefit-risk-cost balance, the variant of nasal administration of Mambisa to be used in stage II of the study.
Y en eso llegó #Mambisa, candidato vacunal que ingresa a la lista global de inmunógenos por vía nasal que avanzan a la fase de ensayo clínico, .... eso bloqueados y asediados.
"And like that came #Mambisa, vaccine candidate entering the global list of nasal immunogens advancing to the clinical trial phase....all while being blocked and besieged. �� Humanitarian aid, GET OUT OF HERE !!!"
Those who undergo this treatment must be people who have been discharged from the hospital for at least two months after contracting the virus and must not be decompensated from their basic or chronic diseases, the expert clarified in the report of Cuba's Caribbean Channel.
Among the benefits of Mambisa, it is worth mentioning that its formulation is the only one of its kind based on the platform of recombinantly produced antigens, a highly safe technology.
The immunogen has registered slight adverse effects and there is the possibility of administering multiple doses in order to reinforce the immunological response over time, said Marta Ayala, general director of the CIGB.
Another advantage is the potential for inducing this type of action in the nasopharyngeal mucosa, which is particularly convenient since it is a vaccine candidate against a disease whose entry point is through the respiratory tract, the scientist pointed out.