J&J's Ebola Vaccine Set to Enter Human Testing
Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point.
J&J said it expects in the coming months to produce more than one million doses of the vaccine, which combines products from J&J and Denmark-based biopharma company Bavarian Nordic.
J&J’s trial design separates the two vaccines, with one administered at the outset and the other given four to eight weeks later. The exact order will be determined in January, J&J spokeswoman Amy Meyer said, adding that these types of vaccine regimens tend to produce strong immune responses.
Results of the initial safety and immunogenicity trials are expected in May 2015, Meyer added. Roughly one quarter of the doses will be held for later-stage clinical trials set to begin after that point, J&J added. The drugmaker also noted it eventually hopes to produce a broader vaccine covering the Ebola, Marburg and Sudan Gulu viruses.
In preclinical testing done with the National Institutes of Health, doses administered two months apart provided 100-percent protection against the Zaire strain of ebolavirus.
The possibility of J&J and GlaxoSmithKline collaborating on the vaccine has been discussed by the CEOs of both companies, GSK spokeswoman Mary Anne Rhyne said. But she noted that GSK’s Ebola vaccine is much further along in clinical testing than J&J’s.
GSK and the NIH kicked off Phase I testing of their vaccine in healthy volunteers in September, with results expected by the end of the year. Rhyne said that the company hopes to begin Phase II testing in frontline healthcare workers in West Africa early next year. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.