Aug. 28, 2014 (San Diego) This morning the director of the National Institute of Allergy and Infectious Diseases (NIAD), Anthony S. Fauci M.D. announced the beginning of accelerated phase I clinical trials for vaccines.
According to the news release:
The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1,400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.
Dr. Fauci told media that this is after the very good success with primate models where they responded and developed immunity.
These Phase I clinical trials will also be carried in the UK, with healthy volunteers, and they hope to expand to Nigeria as soon as they get the necessary permits.
The NIAID and GlaxoSmithKline (GSK) developed the vaccines.
They also explained that:
Phase 1 clinical trials are the first step in what is typically a multi-stage clinical trials process). During Phase 1 studies, researchers test an investigational vaccine in a small group of people to evaluate its safety and the immune response it provokes. Phase 2 clinical trials of investigational vaccines are designed to further assess safety and immune response in larger numbers of volunteers. Under certain circumstances, the vaccine’s ability to prevent infection or disease (called efficacy) can be determined in a Phase 2 trial. Phase 3 clinical trials are directed predominantly at determining efficacy.
This vaccine has the Zaire and Sudan variants of the Ebola, and a second vaccine are being tested which only contains the Zaire variant. None of these clinical trials is expected to be over before the end of 2014. Due to the nature of the emergency the process has accelerated.
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