The Ebola outbreak that has ravaged West Africa for the last two years has finally yielded some welcome good news: A vaccine for the virus protected 100 percent of patients tested in a clinical trial. Merck and drug partner NewLink Genetics recently released the preliminary results of the Phase 3 clinical trial in an analysis published in The Lancet medical journal. Merck said that every patient who received the vaccine was virus free within 10 days.
“We believe that the world is on the verge of an efficacious Ebola vaccine,” Marie-Paule Kieny, assistant director general of the World Health Organization told The Guardian.
Ebola has vexed the biotechnology industry and health care providers, who have struggled to find a way to stop the viral outbreak resulted in nearly 30,000 cases and 11,000 reported deaths. The deadly nature of Ebola called for a novel clinical trial design. Rather than a randomized, placebo-controlled study, clinical trial investigators decided a different approach. The 4,000-patient study still tested the vaccine in two groups of patients in Guinea at risk of infection, The Guardian explained. But one group of patients received the vaccine immediately after exposure to Ebola, while the second group received the vaccine after a delay.
There was still an element of randomization to the study; clusters of patients were randomized to be included in either the first group or the second group. The study did not include children, adolescents, and pregnant women, because researchers did not have enough information about the safety risks posed to such patients.
The trial will continue, but without randomization. Also, since these preliminary trial results have provided safety data, the vaccine will now be offered to children and adolescents. While these early results of 100 percent effectiveness are promising, the study results so far represent a small sample of patients. Vaccines in Phase 3 trials are typically tested in thousands of patients. Kieny told The Guardian that as more study results are collected from larger samples of patients, the efficacy will likely fall to between 75 percent and 100 percent.
Merck’s promising clinical trial results are not last word on new Ebola vaccines. GlaxoSmithKline is also working on an Ebola vaccine that is currently in clinical trials, as is Johnson & Johnson.
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