Monday, October 27, 2014

Agenda of Phase 2 clinical trial of experimental Ebola vaccines

Just heard from the news that two American nurses have been declared cured of Ebola.




Two candidate vaccines have been elected for phase 1 clinical trials.

  • One (cAd3-ZEBOV) has been developed by GlaxoSmithKline in collaboration with the US National Institute of Allergy and Infectious Diseases. It uses a chimpanzee-derived adenovirus vector with an Ebola virus gene inserted.
  • The second (rVSV-ZEBOV) was developed by the Public Health Agency of Canada in Winnipeg. The license for commercialization of the Canadian vaccine is held by an American company, the NewLink Genetics company, located in Ames, Iowa. The vaccine uses an attenuated or weakened vesicular stomatitis virus, a pathogen found in livestock; one of its genes has been replaced by an Ebola virus gene.
The efficacy of those drugs are not completely understood. Gender and race difference may contribute a factor to the drug effect.

WHO has set the key milestones on the agenda in a short time frame:

October 2014:
Mechanisms for evaluating and sharing data in real time must be prepared and agreed upon and the remainder of the phase 1 trials must be started

October–November 2014:
Agreed common protocols (including for phase 2 studies) across different sites must be developed

October–November 2014:
Preparation of sites in affected countries for phase 2 b should start as soon as possible

November–December 2014:
Initial safety data from phase 1 trials will be available

January 2015:
GMP (Good Manufacturing Practices) grade vaccine doses will be available for phase 2 as soon as possible

January–February 2015:
Phase 2 studies to be approved and initiated in affected and non-affected countries (as appropriate)

As soon as possible after data on efficacy become available:
Planning for large-scale vaccination, including systems for vaccine financing, allocation, and use.

As of 25 October 2014, the number of confirmed cases reaches over 10,000 across the countries.
Ref: http://apps.who.int/iris/bitstream/10665/137185/1/roadmapupdate25Oct14_eng.pdf?ua=1

The effect of outbreak control still remains unknown in the world unless a new vaccine is invented and proven to be effective to all races.





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