Pending the results of ongoing Phase I trials, the US National Institutes of Health (NIH) has announced plans to launch, in early 2015, a large, randomized, controlled Phase III study to evaluate the safety and efficacy of the new Merck vaccine, known as rVSV-EBOV, and another potential Ebola vaccine developed by GlaxoSmithKline.
Under the terms of the agreement, which did not reveal any financial details, Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine platform is based on an attenuated strain of vesicular stomatitis virus that has been modified to express an Ebola virus protein.
Originally developed by the Public Health Agency of Canada (PHAC), rVSV-EBOV will now be manufactured in-house at Merck, spokeswoman Pam Eisele told BioPharma-Reporter.com
“The company has considerable experience with the technology used for the manufacturing of the rVSV vaccine in that it’s similar to manufacturing other of Merck’s vaccines,” Eisele told us. “With regards to how many doses will be manufactured and the timing for that, it will depend on the appropriate dose needed for efficacy.”
Merck’s production technology, called Vero, could be used to increase manufacturing capacity for the vaccine. The technique uses cells from African green monkeys to produce vaccines and is already used to make RotaTeq, a vaccine that can help protect babies against common types of rotavirus, according to Bloomberg News.
NewLink initially said it would manufacture 12m doses by April, though that may change because of Merck’s manufacturing capacity.
Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the Walter Reed Army Institute of Research. Additional Phase I studies are underway or planned to begin shortly at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.
“This vaccine is the result of years of hard work and innovation by Canadian scientists. We are pleased that this new alliance coupled with the clinical trials currently underway will further strengthen the possibility that the vaccine will make a difference in the global response to the Ebola outbreak,” said Canada’s Minister of Health, Rona Ambrose.