NewLink Genetics Corporation and Merck have been given the nod to go ahead with the trials by the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) and awarded the contract worth $30 million to NG subsidiary BioProtection Systems.
BioProtection Systems will take up the trial of the rVSV-EBOV (Ebola) vaccine, including clinical development through a new 330-person Phase Ib study. The vaccine was initially developed by the Public Health Agency of Canada (PHAC), and is now being developed under an exclusive licensing and collaboration agreement between NewLink Genetics and Merck. The rVSV-EBOV (Ebola) vaccine is currently under Phase I clinical studies in humans.
“The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate. These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies,” said Dr. Charles Link, CEO and Chief Scientific Officer of NewLink Genetics.
Dr. Mark Feinberg, chief public health and science officer of Merck Vaccines said:”If we can bring an efficacious and well-tolerated vaccine to the outbreak countries, we will not only help protect people at risk in the current crisis, but also may help reduce the likelihood of such tragic events in the future.”
Pending the results of Phase I trials underway, the US National Institutes of Health has announced plans to initiate, in early 2015, a large randomized, controlled Phase II/III study to evaluate the safety and efficacy of this and another investigational Ebola vaccine candidate.
Meanwhile, the University Hospitals of Geneva, which had suspended the trial of an experimental Ebola vaccine licensed by Merck & Co. said it would resume trial after a three-week pause owing to mild joint pain in volunteers.
In a statement, the University Hospitals of Geneva said a second test group of 56 people will be given the vaccine VSV-ZEBOV at a lower dose than the initial group. The test, being conducted on healthy volunteers, will continue through the end of the month with final results expected in March.