On the Homestretch
The process of authorization of a new Russian Ebola vaccine is on the homestretch. Phase II clinical trials have been successfully completed at the Research Institute of Clinical and Experimental Medicine of Siberian department of RAMS (Novosibirsk).
The studies of immunogenicity and safety of a peptide antigen based Ebolva vaccine (EpiVacEbola) involved over 200 healthy volunteers (18 to 60 years old). They were immunized twice within two weeks. In all cases Ebola antibodies were induced, without any complications, which was a good evidence of its efficacy and safety.
Now the drug needs to be approved at the Ministry of Health. Then phase III clinical trials will start in Africa.
It should be reminded that development of a vaccine for hemorrhagic Ebola fever started in Russia in October, 2014. For 15 months the vaccines showed maximum efficacy with excellent safety and good tolerability. In January 2016 the Russian vaccine was introduced at a meeting of WHO executive committee, and on February 15 it was presented at the UN Office at Geneva.
Patients are very likely to receive the first doses of the Russian Ebola vaccine next spring.