Made in Russia: Meningococcal vaccine
"Natsibio" begins clinical trial of the first domestic polyvalent meningococcal vaccine
NPO Microgen, part of the National Immunobiological Company, has started phase I clinical trials of the first domestic polysaccharide meningococcal vaccine against serotypes A and C. Preclinical studies have shown that it is well tolerated, safe and has high immunogenic activity. The first phase of clinical trials will be completed by the end of 2017.
Meningococcal infection is an acute infectious disease. As potentially fatal, this infection should always be treated as a medical emergency.
To create a vaccine, for the first time in the Ufa branch of Microgen, a controlled reactor method of cultivating vaccine strains of meningococci of groups A and C. The new vaccine will be produced in the reconstructed workshop of multicomponent vaccines at the Ufa site of the company using BIOR reactors was introduced.
"The reactor method automates manual labor, is easily reproducible and efficient, and allows you to scale production volumes," he said Sergey Goryunov, First Deputy General Director of Microgen.
Today, Russia does not produce polyvalent vaccines against meningitis of serotypes A and C. Microgen produces polysaccharide meningococcal monovaccine. Thanks to the cooperation of "Microgen" and the enterprise for the production of bacterial preparations named after G.N. Gabrichevsky, it was possible to produce a polyvalent vaccine containing two serotypes of the virus.
"Preclinical studies have shown that when administered to laboratory animals, the vaccine is safe, has good tolerability and does not have a negative effect on generative function," he said Alexey Ershov, Head of the Registration and Medical Research Department of Microgen. "This vaccine can be used as part of the vaccination calendar for epidemic indications."
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29.03.2017