Sunday, January 25, 2015

Some Shifts In Geography "Probable" -- In Large Scale Phase II/III Ebola Vaccines Trials

The good news here is that Liberia is ever so gingerly turning the corner -- on her Ebola outbreak.

Sierra Leone is not yet that fortunate -- so the large, three arm (Merck-GSK-placebo) trials may be conducted (at least in part) outside of Liberia. Sierra Leone is the likely second site. Finding enough volunteers to take nearly 30,000 doses already arriving in West Africa will take a bit, now -- or so says the head of US NIH, Dr. Francis Collins. Here's the minor updating tidbit, sourced from off-hand remarks made at a Davos, Switzerland conference yesterday, EU time:

. . . .A steep fall in Ebola cases in Liberia will make it hard to prove whether experimental vaccines work in a major clinical trial about to start in the country, the head of the US National Institutes of Health (NIH) said on Saturday.

The NIH might have to move some testing to neighbouring Sierra Leone, while regulators could end up approving Ebola shots based on efficacy data from animal tests backed by only limited human evidence, Francis Collins told Reuters. Liberia, once the epicentre of West Africa’s deadly Ebola epidemic, has just five remaining confirmed cases of the disease, a senior health official has said. The sharp decrease in cases is clearly good news, but it poses a problem for scientists from the NIH, GlaxoSmithKline and Merck, who want to enrol 27,000 people at risk of infection in the pivotal Phase III Liberian study. “It’s going to be a hard trial,” Collins said on the sidelines of the World Economic Forum in Davos. “It’s possible we may have to move some of the effort to Sierra Leone. . . ."

Huge soft wheeling snowflakes drifting by my window right now. . . a very peaceful late rising Sunday morning. . . do go enjoy yours. Smile.

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