Russian company starts phase 2 clinical trials of its meningococcal vaccine

NPO Microgen has begun phase 2 clinical trials of the first Russian polysaccharide meningococcal vaccine to prevent diseases caused by Neisseria meningitidis serogroups A and C, including meningitis and meningococcemia.

Phase 2 will include clinical trials of the vaccine efficacy and safety in volunteers. Preclinical studies on laboratory animals and phase 1 clinical trials completed in Q2 2017 confirmed the safety and good tolerability of the vaccine. Phase 2 clinical trials are scheduled for completion in Q2 2018.

“This work is part of import substitution program designed to reduce Russia’s dependence on foreign suppliers in critical areas, including health care. We expect that it will result in the creation of first Russian polysaccharide meningococcal vaccine, which will be able to successfully replace imported drugs and will be used in the national vaccination schedule,” said Oleg Yevtushenko, the Executive Director of Rostec Corporation.

To develop a domestic polyvalent meningococcal vaccine, NPO Microgen implemented a controlled reactor method for cultivation of vaccine strains of meningococcus groups A and C, which allows to automate and promptly scale output of the drug in the event of epidemics.

SOURCE: gmpnews.ru
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