Russian scientists plan to complete the clinical trials of domestically developed inactivated polio vaccine by mid-2018 and are preparing the documents required for the registration of this drug. This was announced by Aidar Ishmukhametov, the Director of M.P. Chumakov Federal Scientific Center for Research and Development of Immunobiological Products of Russian Academy of Sciences.
“In accordance with the applicable law, after the completion of clinical trials, we will submit to the Ministry of Health the complete package of documents for registration of the drug. The clinical trials will be conducted in three phases on more than 600 volunteers. We plan to complete the clinical trials and assess their results by mid-2018,” said Mr. Ishmukhametov.
The innovative polio vaccine was developed by using Sabin strains, the attenuated strains of poliovirus.
“The mechanism of action is traditional – an antigen (inactivated virus) introduced into the body (intramuscularly or subcutaneously) stimulates the immune system of the vaccine recipient, which responds by producing the antibodies that neutralize the virus,” added the director of research center.
He said that, during the trials on animals (rabbits, Guinea pigs, monkeys), the vaccine demonstrated its safety and adequate immunogenicity (ability to generate an immune response against three types of polio virus).