An early-stage human clinical trial
for an Ebola vaccine is likely to begin as early as September, 2014, the US
National Institutes of Health has disclosed.
Though not the first human vaccine
trial for the virus, the study comes after mounting pressure from health
organisations to allow experimental treatments to be used on people at high
risk of developing the disease.
The vaccine, developed by the
National Institute of Allergy and Infectious Diseases, NIAID, Vaccine Research
Center, contains no infectious Ebola virus material. Instead, it is a
chimpanzee adenovirus vector vaccine containing an insert of two Ebola genes.
Adenovirus vectors are attractive
delivery models for vaccine candidates because the virus can be easy
manipulated. As a nonreplicating viral vector, the vaccine works by entering a
cell and delivering the new genetic material.
The new gene inserts cause a
protein to become expressed, which in turn elicits Dr. Anthony Fauci, said the
NIH’s Ebola vaccine has been studied in monkeys.”
If it is successful, it will
take until mid- to late-2015 before a limited number of vaccine doses would be
ready to administer to health care workers, he said.
The clinical trial participants
won’t be exposed to the Ebola virus, Fauci said. Instead, they’ll stay in the
United States, where they’ll be given a dose of the vaccine and tested to see
if their antibody levels match the levels shown in monkey studies to protect
the monkeys from Ebola. Scientists will also be watching for adverse reactions
to the vaccine to make sure it is safe.
Meanwhile, health campaigners have
petitionedo the US Food and Drug Administration, FDA, asking it to speed up the
authorisation of a new drug called TKM-Ebola which is widely believed to be a
cure for EVD. TKM-Ebola is a promising vaccine on trial.
In the petition entitled “Fast track
Drug and vaccine research for Ebola Hemorrhagic fever”, the petitioners said
given that at least one patient has transferred the disease from Liberia to
Nigeria by air travel, the possibility of a global pandemic becomes
increasingly likely.
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