NPO Microgen, part of the National Immunobiological Company, has begun Phase I clinical trials of the first Russian polysaccharide meningococcal vaccine against serotypes A and C. The preclinical studies demonstrated that it is well tolerated, safe and has high immunogenic effect. Phase I clinical trials will be completed by the end of 2017.
To create the vaccine, the Ufa branch of Microgen has implemented a controlled reactor method for cultivating the vaccine strains of meningococcal groups A and C. The new vaccine will be manufactured in a reconstructed shop of multicomponent vaccines at Ufa facility of the company by using BIOR reactors.
“The reactor method automates the manual labor, it is easily reproduced, effective, and allows to scale-up the production volumes,” said Sergei Goryunov, First Deputy General Director of Microgen.
Today, Russia does not manufacture any polyvalent vaccines against meningitis of serotypes A and C. Microgen produces polysaccharide meningococcal vaccine. The cooperation between Microgen and Gabrichevsky Plant for Production of Bacterial Medicines allowed manufacturing of a polyvalent vaccine containing two serotypes of the virus.