Two Ebola vaccines, one developed by the NIH and GlaxoSmithKline ($GSK) and the other by Merck ($MRK) and NewLink ($NLNK), have sailed through Liberian trials and, based on the results, may now advance to Phase III trials.
The single-shot vaccines appeared to be safe based on a double-blind, Phase II trial, sponsored by the NIH's National Institute of Allergy and Infectious Diseases (NIAID), with more than 600 participants. This was the first stage of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) Phase II/III clinical trial.
|NIAID Director Dr. Anthony Fauci|
"We are grateful to the Liberian people who volunteered for this important clinical trial and encouraged by the study results seen with the two investigational Ebola vaccine candidates," NIAID Director Dr. Anthony Fauci said in a statement. "Now we must move forward to adapt and expand the study so that ultimately we can determine whether these experimental vaccines can protect against Ebola virus disease and therefore be used in future Ebola outbreaks."
Enrollment for the Phase II trial will continue through late April to make the data set even more robust, and investigators plan to enroll 27,000 people at risk of Ebola infection in the Phase III trial, the NIH said. While the initial plan was to draw this pool from the Liberian population, the trial leaders have decided to expand the trial to other West African countries, as the number of new Ebola cases is dwindling in Liberia.
Also in the Ebola vaccine race is fellow Big Pharma Johnson & Johnson ($JNJ), which is collaborating with Bavarian Nordic on a two-dose vaccine, and Novavax ($NVAX), which has its candidate in Phase I trials in Australia. The Beijing Institute of Biotechnology published positive results from a Phase I trial on March 24.
- here's the NIH release
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