ICON selected by BARDA to conduct anthrax vaccine clinical trial
06 Octobre 2022 - 2:00PM
Business Wire
ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence
and clinical research organisation, today announces that it has
been selected by the US Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response (ASPR) in the Department of
Health and Human Services (HHS), to execute an anthrax vaccine
clinical trial.
BARDA is providing funding to the Government and Public Health
Solutions team at ICON to develop and execute a clinical trial that
will evaluate the immune response to the next-generation anthrax
vaccine AV7909. The team will support the evaluation of AV7909
immunogenicity kinetics by conducting clinical trial activities
including but not limited to project management, clinical
operations and quality assurance.
ICON has extensive experience in supporting vaccine clinical
trials. It has participated in over 160 vaccine studies in the past
five years. ICON’s vaccine clinical research professionals are
therapeutically aligned with a leadership team that brings more
than 200 years of combined experience in vaccine clinical
development for commercial businesses, government, NGOs and
multinational health organisations.
Edward Wright, President, ICON Government and Public Health
Solutions, commented: “We are pleased to have been selected to
execute this important clinical trial. The potential for an anthrax
attack is still a very real and serious threat, and we are proud to
be playing our part to increase the understanding of treatment
options for anthrax exposure, ultimately supporting human
health.”
This clinical study will inform operational logistics and use of
AV7909 should an anthrax emergency occur. The clinical studies will
not expose participants to anthrax. The trial will enrol healthy
adults aged 18 and older and will be conducted in the United States
starting in early 2023.
BARDA, part of the Administration for Strategic Preparedness and
Response within the U.S. Department of Health and Human Services,
is responsible for developing medical countermeasures to secure the
U.S. against chemical, biological, radiological, and nuclear
threats, as well as pandemic influenza and emerging infectious
diseases. Since 2014, ICON has been a member of BARDA’s Medical
Countermeasures Clinical Studies Network (CSN). The network is
responsible for planning and executing clinical studies to support
medical countermeasure development.
Bacillus anthracis, the agent that causes anthrax, is a serious
bioterrorism threat due to the delivery of aerosolised spores that
can cause high-mortality disease through gastrointestinal,
cutaneous, inhalational (pulmonary), or injection routes. Although
clinical manifestations of the disease differ by route,
inhalational anthrax is the most lethal. Inhalational anthrax
infection usually develops within a week after exposure but can
take up to two months. Without treatment, only about 10% to 15% of
patients survive after exposure to inhaled B. anthracis spores.
Since 2015, BARDA has supported the late-stage development of
AV7909, a next-generation anthrax vaccine which uses the U.S. Food
and Drug Administration (FDA)-licensed anthrax vaccine Biothrax in
combination with an immune system stimulant or adjuvant. The
vaccine is being developed in partnership with its manufacturer
Emergent Biosolutions Inc. to protect against anthrax post-exposure
when used in combination with the recommended antibiotics.
About ICON plc
ICON is the world’s leading clinical research organisation,
powered by healthcare intelligence. From molecule to medicine, we
advance clinical research providing outsourced development and
commercialisation services to pharmaceutical, biotechnology,
medical device and government and public health organisations. We
develop new innovations, drive emerging therapies forward and
improve patient lives. With headquarters in Dublin, Ireland, ICON
employed approximately 40,500 employees in 119 locations in 53
countries as at June 30, 2022. For further information about ICON,
visit: www.iconplc.com.
About ICON Government & Public Health Solutions
ICON Government & Public Health Solutions (GPHS) is ICON's
business unit focused on direct US Government engagement,
Non-Government Organisations (NGOs) and academia, providing full
service and functional research solutions. In addition, ICON GPHS
coordinates a Government Centre of Excellence (CoE) to lend
internal federal government subject matter expertise that can be
leveraged by other ICON business units when commercial clients
receive federal funding on ICON awarded contracts.
About BARDA’s Medical Countermeasures Clinical Studies
Network (CSN)
The CSN provides BARDA partners and medical countermeasure
developers with essential tools and services to develop vaccines,
therapeutics, diagnostics, and medical devices. The CSN provides
comprehensive (Phases 1-4) clinical study services to help evaluate
the safety, dosage, pharmacokinetics/pharmacodynamics,
immunogenicity, and efficacy of medical countermeasure candidates,
provide long-term storage services for clinical and nonclinical
biological specimens and investigational products for future
assays, and provide a statistical and data coordinating centre for
harmonisation across BARDA projects. ICON plc’s work with BARDA is
supported with federal funds under contract number
75A50120D00017.
ICON/ICLR-G
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version on businesswire.com: https://www.businesswire.com/news/home/20221006005215/en/
Media: Claire Quinn (GMT time zone) Corporate
Communications, ICON plc +353 87 4066091 claire.quinn@iconplc.com
Weber Shandwick (PR adviser) Lisa Henry (GMT time zone)
lhenry@webershandwick.com +447785 458203
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