Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone

Merck (MSD outside the US and Canada) and NewLink Genetics Corporation have confirmed that the third, late-stage, clinical trial of their Ebola vaccine candidate rVSVZEBOV-GP (V920) has been initiated in Sierra Leone. The vaccine candidate was originally developed by the Public Health Agency of Canada’s National Microbiology Laboratory and licensed to NewLink Genetics in 2010. On 24 November 2014, Merck and NewLink Genetics announced an exclusive licensing and collaboration agreement for the investigational Ebola vaccine.

The Phase II/ III safety and effectiveness study, called STRIVE (Sierra Leone Trial to Introduce a Vaccine against Ebola) taking place in Sierra Leone will involve 6000 health and other frontline workers and is being led by the Sierra Leone College of Medicine and Allied Health Sciences, Sierra Leone Ministry of Health and Sanitation, and the U.S. Centers for Disease Control and Prevention (CDC).

“Fighting Ebola remains a global health priority, and Merck is committed to advancing the development of our and NewLink’s vaccine candidate as part of our overall response to the crisis,” said Mark Feinberg, chief public health and science officer, Merck Vaccines.

The Merck and NewLink rVSV-ZEBOV-GP vaccine candidate is now included in three large-scale clinical trials currently underway in West Africa. In addition to the trial in Sierra Leone, these trials are

• The Partnership for Research on Ebola Vaccines in Liberia (PREVAIL): Led by a Liberia-US clinical research partnership and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), PREVAIL was designed to enroll approximately 27,000 healthy men and women aged 18 years and older. This randomized, controlled Phase II/III study to evaluate safety and efficacy, involves rVSV-ZEBOV-GP and nother experimental Ebola vaccine. Based on declining Ebola virus incidence in Liberia, the trial leaders have determined that it is scientifically appropriate to expand the trial to additional sites in other West African countries. Discussions are underway to explore that possibility, but the trial has not yet expanded outside of Liberia.

• Phase III study in Guinea: The World Health Organization (WHO), the Health Ministry of Guinea, Médecins sans Frontières (MSF), Epicentre and The Norwegian Institute of Public Health have initiated a safety and effectiveness study investigating Merck’s and NewLink’s rVSV-ZEBOV-GP, the vaccine candidate that was selected by the WHO and study partners to be assessed first in this study.