HAVANA, Cuba, Feb 5 (ACN) The Center for Genetic Engineering and Biotechnology (CIGB) expects to advance in March to Phase III of the clinical trials of the Abdala vaccine candidate (CIGB-66), after more than 300 individuals participated in the second stage of its short vaccination scheme.
Marta Ayala Ávila, Director General of the institution, pointed out that Phase II expanded the age of the volunteers to include now from 19 to 80 years old.
She said that the trial, which is being carried out at the Saturnino Lora Hospital in Santiago de Cuba, is blind and randomized and evaluates the safety and immunogenicity of the Cuban drug.
Abdala explores the intramuscular route, from a recombinant variant adjuvant in aluminum hydroxide, with proven use in humans for many years and which also induces systemic response, Ayala Avila stressed.
She explained that in the first phase of studies 132 volunteers were included in six groups, so far all of them received the second dose and had an intense and high response of specific antibodies.
She emphasized that the candidate is capable of neutralizing the binding of the virus to the cell; hence the second phase of the vaccination scheme will begin this week.
She also said that the CIGB is developing the Mambisa clinical trial (CIGB-669), which explores the nasal route and takes advantage of the precedent result of the recombinant vaccine against hepatitis B.
This platform induces innate immunity and when combined with a specific antigen can give a potent formulation, Ayala Avila pointed out.
She mentioned that it is attractive to evaluate the nasal route, because it is very friendly and the port of entry of the virus.
She explained that molecular studies show that the mucosal response fails and that is why the virus can continue to penetrate and affect the respiratory system; therefore, this route, in addition to stimulating the antibody response, can also be a very effective way of combating SARS-CoV-2.
The Mambisa clinical trial included 88 volunteers, distributed in four study groups, at the National Toxicology Center in Havana and on day 56 all participants received the three vaccine doses.
The general director of the CIGB said that the Mambisa vaccine candidate has proven to be safe and well tolerated, with mild adverse events that resolved spontaneously; therefore, once the analytical activity is concluded, phase II is expected to begin.
She commented that for CIGB-66 and CIGB-669 they established two immunization schedules, a short one, with three immunizations in one month, and a long one, with three immunizations spaced two months apart.
The short schedule allows a rapid evaluation of the immune response in pandemic conditions.
Since the beginning of COVID-19, the center has used all its products and molecules to respond to the health situation with drugs that are currently part of the Cuban action protocol.
The CIGB has experience in the development of vaccines and continues to work on other candidates for diseases such as dengue, Zika and immunotherapies against cancer
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