Russia is developing a recombinant cholera vaccine

Print 26 June 2018
GMP News

Scientists from the State Research Institute of Highly Pure Biopreparations of the FMBA of Russia are developing a cholera vaccine. Unlike traditional vaccines, it will be created without using any living bacteria fragments. New vaccine will include recombinant proteins that induce the body’s immune response.

“The recombinant vaccine contains an artificially created analog of human protein,” said Andrey Simbirtsev, a Corresponding Member of RAS. “Specific immunity functions as a “key-lock” system. The primary contact with the pathogen or, in our case, a protein similar to the pathogen protein, leads to recognition and subsequent production of immunoglobulins which, in case of repeated contact, can recognize such “pathogenic key” and promptly activate the protection mechanism. If there are no specific antibodies, the immune response would have to be formed “from scratch,” and this would take more precious time, during which a virus or bacteria can win.”

State Research Institute of Highly Pure Biopreparations used genetic engineering to artificially create the “keys” based on the part of bacteria protein so that the immune system can respond and begin to produce immunoglobulins capable of recognizing bacteria without need to inject a pathogen. This is important because even a weakened substance (included in a vaccine with neutralized bacteria or their fragments) has many different proteins and metabolites that can lead to unwanted side effects. Such effects may include severe forms of allergic reaction, arthritis, etc., especially if the patient has suppressed immunity. Therefore, the use of recombinant vaccine enables effective protection with much greater safety.

The research institute can ensure full-cycle manufacturing of the new vaccine. The drug has passed the stage of pilot studies, which demonstrated encouraging results. Preclinical studies have already started, after which the new vaccine will go through the clinical trials.

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