Corporation today announced that enrollment has commenced in a Phase
I clinical trial to evaluate VAX161, its novel H5 vaccine candidate in
development for the prevention of pandemic avian influenza or bird flu.
VaxInnate is a biotechnology firm pioneering breakthrough technology for
developing novel vaccines.
The study is being conducted under VaxInnate's contract
with the Biomedical Advanced Research and Development Authority (BARDA),
part of the U.S. Department of Health and Human Services (HHS). The
trial will evaluate the safety and immunogenicity of VAX161.
The dose-ranging study evaluates the safety and immunogenicity of two
doses of VAX161 given by intramuscular injection three weeks apart at
six dose levels ranging from 1µg to 12 µg. The study includes 250
healthy adults aged 18-49 years. The study is expected to yield data
that will enable VaxInnate to select the appropriate dose of VAX161 for
further development. Results are expected late this year.
"The objective of this study is to optimize the dose, based on the
immunogenicity and safety of VAX161," said David Taylor, MD, Chief
Medical Officer. "We believe our vaccine candidate has the potential to
be a highly effective and much-needed vaccine for pandemic avian flu."
VAX161 is a recombinant fusion protein that consists of the globular
head domain of the hemagglutinin antigen (HA) of influenza A HA5
Indonesia fused to Salmonella typhimurium flagellin type 2
(STF2), a toll-like receptor 5 (TLR5) ligand. The H5N1 Indonesia strain
belongs to the family of highly pathogenic avian influenza viruses.
VAX161 is a prototype of what would ultimately be a single-component,
two-dose pandemic avian flu vaccine.
Although H5N1 is primarily an influenza virus of birds, it has been
infecting humans for at least 25 years. Between 1987 and early 2012, the
World Health Organization confirmed H5N1 infections of 584 people and
345 deaths in 15 countries. The human mortality rate resulting from H5
influenza can be as high as 60%. So far, most avian flu infections were
transmitted from birds to humans and person-to-person transmission has
been limited. However, scientists worry that genetic recombination or
mutation will eventually occur, increasing human-to-human transmission
and resulting in an outbreak or pandemic. It is this potential that
makes avian flu vaccines a global public health priority.
"We believe VaxInnate's approach to vaccine development holds a great
deal of promise for avian flu and look forward to learning more about
the potential of VAX161 in this clinical trial," said principal
investigator Casey Johnson, DO of Johnson
County Clin-Trial (JCCT) in Lenexa, Kansas. The study is also taking
place at Miami
Research Associates (MRA) in South Miami, FL, under the supervision
of principal investigator Eric Sheldon, MD.