Johnson & Johnson (JNJ) Starts Ebola Vaccine Testing in Humans
1/6/2015 5:54:43 AM
January 6, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Johnson & Johnson (JNJ) today launched the Phase 1 clinical trial of its Ebola vaccine candidate, which is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Pediatrics. J&J’s vaccine candidate is now the third Ebola vaccine currently being tested on humans, joining a group that includes the Merck-NewLink vaccine and the GlaxoSmithKline (GSK) vaccine.
J&J’s Ebola vaccine differs from the Merck-NewLink and GlaxoSmithKline candidates, because the therapy consists of two separate injections. Volunteers are first given a dose to “prime the immune system, and then a boost intended to enhance the immune response over time,” according to J&J.
J&J’s Ebola vaccine is in development at its Janssen Pharmaceutical Companies, which in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015.
When the U.S. National Institutes of Health conducted pre-clinical experiments of the regimen that involved the initial shot and booster shot administered two months apart, “complete protection from death due to Ebola” was observed against the Kikwit Zaire strain of the disease, according to the company. The Kikwit Zaire strain resembles the virus responsible for the current outbreak in West Africa.
The initial human trial at the University of Oxford will include 72 healthy volunteers, who will receive either the vaccine therapy or a placebo. Eventually 300 volunteers will be involved in the Phase I trial, with Phase III trials planned to begin by the second quarter of 2015, according to CNBC.
“Because every day counts, we are substantially accelerating the production of our vaccine regimen,” said Paul Stoffels, chief scientific officer and worldwide chairman of pharmaceuticals at J&J. “Through the unprecedented collaboration among the global health community, our goal is to bring this vaccine to families and frontline health care professionals as fast as possible.”
A doctor from the Oxford Vaccine Group emphasized the importance of both speed and of having several vaccine candidates simultaneously in human clinical trials.
“The fact that there are at least three Ebola vaccines entering these early safety trials is good news,” Matthew Snape of the Oxford Vaccine Group was quoted as saying by the BBC. “We are not playing first past the post here. Having multiple vaccines progressing through clinical trials increases the likelihood of vaccine manufacturers having the capacity to meet production demands should mass immunization be required,” Snape continued. “The more vaccines and more manufacturers there are working on this, the better.”
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