Monday, January 5, 2015

Swiss Arm Of The Ebola Vaccine Trials Resumes -- On Track -- And Generally As Expected

It seems as though (in the land of karmic surprises) the Merck/NewLink/Canadian candidate may be equally effective at a lower single dose, thus obviating any need for a "prime plus booster" approach, in this outbreak. That "prime plus booster" is the GSK version's current approach, because the GSK simian container is proving to be less effective at lower doses (thus far). Still a long way to go, yet though, for both candidates.

Here is Reuters -- re-covering a local Swiss (Geneva) story, overnight -- do go read it all:

. . . .The Geneva hospital announced on Dec. 11 that its vaccine trial had been suspended as a precautionary measure after four patients complained of joint pains. . . .

Swissmedic, the Swiss regulatory agency, and ethics and safety committees have approved the resumption of the trial at a lower dose, the hospital said in a statement.

"The second part of this clinical trial will now test a dose of 300,000 vaccine particles, which should be better tolerated by volunteers and will hopefully trigger the production of enough antibodies," it said, noting that the initial phase had 10 million to 50 million vaccine particles.

"Fortunately", it said, the Merck-NewLink candidate vaccine "seems able to induce the production of antibodies at lower doses than those previously used" in the Geneva trial.

Vaccinations have now resumed for the last 56 volunteers, who will receive either a low dose of the vaccine or a placebo, by groups of 15 each week through January, it said. . . .

So we remain cautiously optimistic that the livestock "cold" container will prove to be effective with a single dose -- and thus be a realistic solution in West Africa, to stem this tragic outbreak.

1 comment:

Birdman said...

Excellent news! However, it is very strange that this only occurred in the Geneva study and not the WRAIR, NIAID, Nova Scotia, Gabon or Kenya studies. You might notice there were no clinical holds issued in the US by the FDA. This implies they were not overly convinced the "joint pain" was related to the vaccine. This situation is beyond my comprehension. However, with all the press on this issue I expect that this will seed the idea of "joint pains" in many future clinical trial volunteers. I am thankful for randomized PLACEBO controlled studies. These should sort out fact from fiction. However, there is nothing we can do about "bad press".