Russia’s Promising Combined Ebola Vaccine: Phase III Trials To Start In 2016

Russian Health Minister Veronika Skvortsova said today that two “highly effective” vaccines against Ebola have been developed over the course of 15 months in Russia. The combined vaccine GamEvac-Combi was presented during a briefing, with the two scientists who developed it, who own the intellectual property rights on the vaccines in Russia.

The search for vaccines against Ebola followed a meeting between World Health Organization Director General Margaret Chan and Russian President Vladimir Putin in October 2014, during which an agreement was reached to include Russia in the fight against Ebola and a national plan was formulated, Skvortosa said today during the briefing on the vaccine held at the United Nations in Geneva.

In 2015, preclinical investigations were conducted in laboratory conditions on primates as well as clinical trials (phase I and II) based on the results of these investigations, she said. Two vaccines were registered in Russia, with permission for use, she explained. Both vaccines (GamEvac and GamEvac-Combi) were developed in the Scientific Research Institute of Epidemiology and Microbiology.

According to Denis Logunov, deputy director of the Ivanovsky Virology Institute, the “combinated vectored vaccine GamEvac-Combi” is made of two components, which are not used at the same time, he explained. It is called a “booster” vaccine. This type of vaccine has been used because booster immunisation is more efficient, he said.

Logunov said GamEvac-Combi “induces a strong and fully protective immunity” against Ebola in primates. The combination vaccine is safe, he said, with no registered serious adverse effect during clinical trials. Phase III clinical trials are planned (large-scale clinical trials to test the drug on patients to assess efficacy, effectiveness and safety), he said, and will be conducted in 2016.

Alexander Gintsburg, director general of the institute, was asked a question about the potential price of the future vaccine. He said naming an actual price would not be appropriate at the moment since the price does not only reflect the production cost which may vary hugely, but is also determined by the market in which the vaccine is sold.

On a question about who owns the intellectual property rights on those vaccines, Skvortsova said the vaccines have been patented in Russia and the exclusive Russian IP rights belong to Gintsburg and Logunov.

[Update: Asked about the two new Russian vaccines, the WHO said the secretariat “would be very happy for an opportunity to review the safety and immunogenicity data of the two Russian vaccines.”]

Image Credits: Catherine Saez