HAVANA, Cuba, Apr 14 (ACN) Mambisa, a vaccine candidate developed by the Cuban Center for Genetic Engineering and Biotechnology (CIGB), is one of the five nasal vaccines in the world now in the stage of clinical trial, CIGB director Marta Ayala Avila told the daily Granma.
The Doctor of Sciences added that the formulation is also the only one of its kind based on the platform of recombinant antigens, a technology with a number of advantages, including the safety level (few, slight adverse effects have been recorded), the possibility of giving multiple doses to strengthen the immune response over time, and its potential to act on the nasopharyngeal mucosa, which is particularly convenient, as it is a vaccine candidate against a disease whose entry point is through the respiratory tract.
In 2015, the CIGB registered HeberNasvac, the first nasal spray therapeutic vaccine in the world against a chronic infectious disease (chronic hepatitis B).
“We used for Mambisa one of the proteins of that product: the nuclecapsid, a protein that forms the nucleus of the virus and is capable of stimulating an immune response. At present, this vaccine candidate has completed the Phase I clinical trial with 88 volunteers.”
Dr. Gerardo Guillén Nieto, Director of Biomedical Research at the CIGB, said that at that stage the drug showed a good level of safety, and the preliminary results revealed an effective immunological action.
Likewise, in studies carried out with people who suffered from the disease during the first peak of the epidemic in Cuba, Mambisa proved to be a good candidate to reinforce the immune system after a single dose.
There are plans to coordinate with hospitals a Phase I/II clinical trial on people previously infected with the virus. Those selected will receive a single dose of the Mambisa candidate with a view to an assessment of its safety and capacity to boost the subject’s immune system, the scientist explained.
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