At its growing East Baltimore facility, Emergent BioSolutions has produced a booster shot to go with a leading Ebola vaccine candidate, joining a competitive race to make a safe and effective tool to stop the spread of an outbreak that continues in West Africa and to prevent future outbreaks.
Emergent announced Monday that it manufactured a batch of vaccine to be used in a trial expected to start this month in the United Kingdom. The research subjects already will have received injections of a vaccine developed by GlaxoSmithKline and the National Institutes of Health — the same tested in a trial at the University of Maryland School of Medicine — but will receive the booster to see if it can improve upon a lackluster immune response in human subjects.
Gaithersburg-based Emergent's attachment to the Ebola vaccine candidate, among those closest to regulatory approval and commercial sale, could be a significant opportunity, though an executive said the company has not signed any deal to produce the vaccine beyond the first batch. Competition among various vaccine candidates remains fierce, and no front-runner has emerged.
The chance comes as Emergent is preparing for a significant expansion of its labs near Johns Hopkins Bayview Hospital, driven largely by a relationship with the federal government under which it stands ready to mass-produce flu vaccines in an emergency. Emergent is also in talks with the government about possibly producing ZMapp, an experimental drug used on some Ebola patients.
Emergent signed deals to produce the vaccine late last year with British drugmaker GlaxoSmithKline, the NIH's National Institute of Allergy and Infectious Diseases and the University of Oxford, and was able to manufacture it in about three months, said Adam Havey, an Emergent executive vice president who heads the company's biodefense division. Company officials would not say how many doses it produced, but said it was enough for a trial planned at Oxford's Jenner Institute.
The trial, expected to begin this month, comes as researchers seek to test whether a two-vaccine approach would stimulate a better immune response than using the GlaxoSmithKline/NIH vaccine alone. The first vaccine uses a chimpanzee cold virus to deliver Ebola virus proteins into the body, tricking the immune system into recognizing it as Ebola and training it to fight the deadly virus.
It has been tested in human volunteers at NIH, Oxford, and, last fall, at the University of Maryland School of Medicine's Center for Vaccine Development. The center also has administered it in trials in Mali.
The Oxford researchers published results in January showing the vaccine is safe and effective, though some critics said it prompted less of an immune response than would have been expected based on previous tests on primates. The researchers said in December that they would pursue tests of a second vaccine — the one Emergent produced — on half of the 60 volunteers in an initial trial there
"If a single dose of an Ebola vaccine is sufficient, it makes absolute sense to use that," said Professor Adrian Hill, who lead's Oxford's Jenner Institute, in a news release. "But it also makes sense at this early stage of trials to see if a second booster vaccine can greatly increase the levels of immune responses produced."
Instead of a chimpanzee cold virus, the Emergent vaccine uses a modified type of virus that includes chicken pox to deliver Ebola proteins and create immunity to the virus.
GlaxoSmithKline and NIH, working with Emergent, aren't the only team pursuing a possible two-vaccine strategy. Johnson & Johnson is working with Danish company Bavarian Nordic to add a vaccine similar to Emergent's to be used to boost its own.
But it remains to be seen if that strategy will be successful, said John Eldridge, chief scientific officer at Baltimore biotechnology company Profectus BioSciences. Profectus is working on its own Ebola vaccine candidates.
Using a series of two distinct vaccines would require complicated supply chains and administration, especially in a place like West Africa, where Ebola has killed more than 10,000 people in the past year.
"It becomes a challenge from an implementation standpoint," Eldridge said.
But if it proves successful, Emergent's Havey said the company is ready to step in.