University of Wisconsin experts are leading a $3 million effort to create as many as 1000 doses of an experimental Ebola vaccine that will be tested during clinical trials in Japan mid-2019.

Ebola is a severe and often fatal human pathogen. There are periodic outbreaks of this disease in sub-Saharan Africa, including the epidemic that occurred between 2013 and 2016 in Sierra Leone, Guinea and Liberia, according to a Waisman Center press release.

Within humans, Ebola can be spread through close and direct physical contact with vomit, feces and bodily fluids from someone who is infected with the virus. It can also be transmitted from eating meat from non-domesticated mammals, reptiles, amphibians and birds, contact with surfaces and materials contaminated with these fluids, and from the usage of contaminated needles and syringes.

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The effort to bring this vaccine to the clinic is being led by School of Veterinary Medicine professor and global expert on Ebola and influenza Yoshihiro Kawaoka, with experts from Waisman Biomanufacturing.

Normally, an Ebola virus has seven genes that are needed to replicate. The work Kawaoka and Waisman Biomanufacturing is doing comes from the discovery of Delta VP30, a form of the Ebola virus that isn’t infectious and is safe to work within laboratory conditions.

Delta VP30 was discovered by Peter Halfmann, a scientist in Kawaoka’s lab, more than a decade ago. Delta in genomics basically means deletion, so Delta VP30 is a Ebola virus without the VP30 gene, Halfmann said.

“Delta VP30 is just like an authentic Ebola virus, except that I was able to pluck out one gene,” Halfmann said. “That one gene [that I took out] was VP30.”

Because Delta VP30 is missing one gene, it cannot replicate or infect other cells. Halfmann then developed cell lines with the Delta VP30 gene in monkeys, which resulted in Delta VP30 being present to compliment the replication-defective virus, in turn making the body naturally create a defense for the virus. The vaccine has already been proven to be effective when tested on monkeys.

Though the research was done on monkeys, Halfmann expects the results to be the same with humans.

“When applied to humans, it’s just a vaccine,” Halfmann said. “It won’t replicate or do anything. It’ll just give all the proteins to the immune system, so they could make antibodies in an efficient response.”

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Since vaccines work by exposing our immune system to a virus or parts of it, Delta VP30 effectiveness comes from the fact that it is a whole-virus vaccine, Halfmann said.

This means unlike other Ebola vaccine candidates who use vector viruses to ferry a single Ebola protein — a surface antigen — in order to strengthen the immune system, Delta VP30 presents all the viral proteins to the immune system, Halfmann said. This can result in increased and broadened immune responses compared to vaccines that only use a single viral antigen, he added.

Both Kawaoka and Halfmann went to Sierra Leone in December 2014, where they were able to see the frightening effects of Ebola. In Sierra Leone, they had a lab in Freetown and access to a military hospital with 12 treatment beds. Because of this, they were able to continuously keep up with the patients and study the disease.

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Being able to study the disease in person lead to Kawaoka determining his goal, which is to produce a safe and effective vaccine against Ebola virus for people.

In order to do so, Waisman Biomanufacturing, a specialized facility whose goal is to help translate scientific discoveries into early-stage clinical trials, will be working on producing the vaccine, the facility’s managing director Carl Ross said.

Ross stressed how Waisman Biomanufacturing’s goal is to help create the vaccine quickly, efficiently and cost effectively so it can move into clinical trials. Ross also hopes this experience will foster a relationship between Waisman Biomanufacturing and UW, so more work can be done together in the future. 

“Right now, [the Waisman Center is] making the cell bank to produce the virus, as well as doing the process development to make the clinical product and develop quality control assays to release the product for human use.”

There is a scheduled meeting in April 2019 to talk about possibly starting human clinical trials for this vaccine in the U.S.

The trials in the U.S. are tentatively set for late 2019 or early 2020.