The Cuban regulatory authority, the Centro para el  Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CEDMED, in Spanish) authorized on Wednesday, August 11th, the beginning of a Phase II trial with the vaccine candidate CIGB 2020, created at CIGB to stimulate and immune response against acute respiratory infections, including those associated to coronavirus.

This was informed on his Twitter account by Dr. Gerardo Guillén, director of Biomedical Research at the CIGB.

The study seeks to evaluate the safety and effects of the CIGB 2020 on subjects aged 60 years or older, close contacts of patients diagnosed with acute respiratory infections compared to a control group of the same population, the scientist announced on his social network.

This is a product that is nasally and sublingually applied in order to stimulate immunity at this local level due to it is an entry gateway to the virus.

Dr. Gerardo Guillén pointed out to Cubadebate that this a controlled-open study. Prior to this one, a Phase I essay was developed at Hospital Naval, with suspects patients with respiratory symptoms.

Julio César Aguilar, leader of the project, told ACN (Agencia Cubana de Noticias) that the formulation was conceived for the elderly, since their congenital immunity is weakened due to the phenomenon of the inmunosenescence.

In the future, he said, this drug could be used in subjects with comorbidities that reduce their response to this pathogens and in others with early infections by the agent that causes Covid-19(SARSCOV 2).

The researcher explained that CIGB 2020 is designed for pandemic and post-pandemic periods because a product like this will allow a rapid response to the appearance of new strains or viruses of the SARS family, which are capable to avoid the vaccines ‘effects and in the context of respiratory infections, are one of the main causes of adult and pediatric deaths.

Aguilar confirmed the satisfactory results of the Phase I of Profiria clinical trial with 56 volunteers, which led to the second stage, recently approved by Cuba’s regulatory authorities, which is planned for 3000 subjects over 60 years of age in several locations in the country.

In this regard, he said that Phase II plans to analyze pot-exposure prophylaxis in elderly people identified as close contact of patients infected with Covid -19 or other respiratory infections.

He said that the Centro Nacional Coordinador de Ensayos Clínicos, will monitor the process and will guarantee the good clinical practice compliance during the research that will carry out health specialist and health workers in the capital and other territories.

Due to evidences in the Coronavirus, influenza and rhinovirus’ capacity of evade detection mechanisms of the innate immune system and that the stimulation of viral RNA receptors have character in the models of lethal SARS infections, the CIGB bets on the administration of the HeberNasvac vaccine, for the treatment of chronic hepatitis B, as function of acute respiratory infections.

Among the components of the immunogenic is the nucleocapsid antigen of the Hepatitis B virus, also used in the vaccine candidate against Covid-19 convalescents Mambisa, he commented that this candidate’s natural-immunity stimulating properties make its use interesting as a broad-spectrum anti-infective vaccine.

This immune-modelling oriented process arose from the characterization of the molecular mechanisms of action of HeberNasvac.

Its use in post-exposure prophylaxis to Acute Respiratory Infections started from the knowledge of the immunological potential of the formulation during 2019, but its application in this sense occurred during the pandemic, said the doctor in Sciences.

Together with the CIGB 2020 and Mambisa, the prestigious institution developed the Abdala clinical trial, which became the first-anti Covid-19 vaccine produced in Latin America, which revealed a 92.29% efficacy in the prevention against the symptomatic disease and it is currently used in the mass immunization of the Cuban population.

Source: Cubadebate and ACN