BioMARC manufacturing vaccines for Department of Defense

Colorado State University is aiding in the development of vaccines to protect U.S. soldiers from Ebola and Marburg, both deadly diseases caused by filoviruses.

BioMARC,[1] a high-containment biopharmaceutical facility operated by CSU, is manufacturing the vaccines for the U.S. Department of Defense in support of human clinical trials.

The CSU center received the $2 million subcontract through the DOD’s Medical Countermeasures Systems Joint Vaccine Acquisition program, which develops, procures and stockpiles vaccines to protect soldiers from biological warfare agents.

“Colorado State has long been on the front lines of fighting infectious diseases in humans and animals – from retroviruses to vector-borne viral diseases,” President Tony Frank said. “We’re proud now to be able to put our resources and expertise to work in the pressing fight against Ebola.”

Since Ebola was detected in late 2013 in Guinea, the deadly virus has spread into other West African countries, Europe and even the United States.

As of Oct. 22, the Centers for Disease Control and Prevention reported more than 4,800 people have died from Ebola– making it the worst outbreak since the virus was discovered in the 1970s.

“BioMarc is well positioned to contribute advanced manufacturing assets to important global problems such as Ebola,” said CSU’s Vice President for Research Alan Rudolph. “It is a unique asset for CSU, and we are excited to help the Defense Department execute this important vaccine development program.”

Using non-infectious particles

[2]BioMARC will begin manufacturing the vaccines by the end of the year, using a technique called Viral Replicon Particles, which does not use live or infectious viruses.

“This is a fairly new technique that requires cutting-edge equipment, which CSU has invested in at BioMARC,” said Dennis Pierro, a CSU professor and director of BioMARC. “One of the reasons we were awarded this contract is because BioMARC has the unique infrastructure to handle this kind of VRP technology.”

With conventional vaccine techniques, live viruses are grown in a laboratory so antigens can be extracted. (Antigens are the part of a virus or bacteria that causes the immune system to attack the virus and produce antibodies to prevent infection.) Other substances are then added to bolster the body’s immune response to the antigen and extend the vaccine’s shelf life.

The VRP technique eliminates the need for a live virus.  Instead, a small particle called a replicon (a genetically engineered protein production system) is matched with a non-infectious single antigen from the target virus.

This non-infectious particle is then used to replicate antigens and serves as the basis for the vaccine. Like conventional vaccines, substances are then added to increase shelf life and enhance the immunological response.

To date, there are no licensed or U.S. Food and Drug Administration-approved human vaccines or therapeutics to protect against or treat infections caused by Ebola and other filoviruses. Diseases caused by these viruses have high mortality rates; as many as 90 percent of those infected may die.

While BioMARC is developing the Ebola vaccine for soldiers, it could potentially be used to protect others.

“The military wants to protect its soldiers but it is possible that such a vaccine could be used for endemic outbreaks of filovirus infection,” Pierro said.