Swissmedic OKs trial of GSK's adenovirus-based Ebola vaccine
Regulator Swissmedic approved the trial last night, giving WHO researchers at Lausanne University Hospital (CHUV) the all clear to start administering the vaccine to 120 healthy volunteers.
Marie-Paule Kieny, Assistant Director General for Health Systems and Innovation at WHO said: “These are dosing and safety trials being held in advance of to Phase II and III trials currently scheduled for late 2014-early 2015.”
She added that: “If shown to be safe and effective, either of the vaccines could be scaled up for production during the first quarter of next year, with millions of doses produced for wide distribution in high-risk countries.”
GSK’s vaccine – which is a modified non replicating version of a Chimpanzee adenovirus that carries a version of a protein present on the Ebola virus – is one of two candidate anti-infective being tested in Switzerland.
According to the WHO a second vaccine, rVSV-ZEBOV, a version of a weakened vesicular stomatitis virus (VSV) developed by the Public Health Agency of Canada and licensed by NewLink Genetics – will be studied concurrently at Geneva University Hospital.
GSK production
UK drugmaker GSK began making stocks of the vaccine for Lausanne trial in September as part of a batch from which it also supplied an ongoing Phase I study at the NIH Clinical Center in Bethesda, Maryland, US.
GSK spokeswoman Mary Rhyne told BioPharma-Reporter.com the firm was working with data provided by recent acquisition Okairos – which developed the adenovirus-based Ebola preventative – to scale up manufacturing.
