NewLink, Merck initiate Phase II/III Ebola trial in Sierra Leone

In 2010, NewLink Genetics licensed Ebola vaccine candidate from its original developer the Public Health Agency of Canada’s National Microbiology Laboratory.

Merck and NewLink have entered into an exclusive licensing and collaboration agreement in November 2014 for the investigational Ebola vaccine.

STRIVE will include 6,000 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 US Centers for Disease Control and Prevention (CDC).

Merck Vaccines chief public health and science officer Mark Feinberg said: "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."

Currently, the rVSV-ZEBOV-GP vaccine candidate is included in three large-scale clinical trials currently underway in West Africa.

In addition to the Sierra Leone trial, other trials include the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) and a Phase III trial in Guinea.

The randomized, controlled Phase II/III PREVAIL trial will enroll around 27,000 healthy men and women aged 18 years and older and is led by a Liberia-US clinical research partnership and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

The PREVAIL trial is designed to evaluate safety and efficacy, involves rVSV-ZEBOV-GP and another experimental Ebola vaccine.

The Phase III trial in Guinea which will evaluate safety and effectiveness of rVSV-ZEBOV-GP is conducted by the World Health Organization (WHO), the Health Ministry of Guinea, Médecins sans Frontières (MSF), Epicentre and The Norwegian Institute of Public Health.