FDA issues partial hold on Tekmira's Ebola vaccine trials
The order was issued to allow the company to engage in multiple dosage practices for the healthy volunteers in the study. The company stated that trials are expected to continue within a few weeks.
In July of 2014, the company's trial received a full hold with concerns about the health and safety of volunteers concerning the proposed multiple doses with gradual increases within the trial. Tekmira was required to provide additional information and to modify this portion of the trial.
It was adjusted to a partial hold in August 2014, to allow the vaccine candidate to be given to individuals with suspected cases of the Ebola virus disease.
Volunteers in the study will receive daily doses of the candidate or a placebo for up to seven days. Results are expected by the latter half of this year.
The candidate showed successful results in preclinical trials with animal models. The group reported 100 percent protection for subjects that received the candidate; it also showed the treatment capabilities for animals that had been infected with the disease.