GlaxoSmithKline initiates human trial programme with two h5n1 pandemic flu vaccines
May 24, 2006: GlaxoSmithKline (GSK) has announced the start of an international clinical trial programme to test two
pandemic vaccines against the H5N1 strain of the avian influenza virus in humans. This dual approach reflects the
company’s commitment to provide health authorities with concrete options to face the threat of a pandemic.
A clinical trial just initiated in 400 healthy adult volunteers in Germany is testing a pandemic flu vaccine using a
classic alum adjuvant to improve individuals’ immune response and possibly allow a lower amount of antigen to be used
per dose. This trial supports a dossier GSK submitted to European regulators in December 2005. Should a pandemic flu
strain be identified by the World Health Organisation, a variation to the dossier would allow rapid European
registration and production of a pandemic vaccine.
In parallel, a clinical trial conducted in Belgium in 400 healthy adults is testing a candidate pandemic flu vaccine
that contains a novel adjuvant system. GSK is hopeful that a vaccine formulated with this novel adjuvant will further
enable individuals’ immune system to respond to different H5N1 virus strains, offering a broader protection against the
threat of a pandemic. GSK novel adjuvant technology is also expected to further reduce the amount of antigen needed per
dose, increasing the number of doses the company could make available worldwide. Such a vaccine would offer governments
additional options of stockpiling and vaccinating ahead of a pandemic outbreak.
Both trials are testing the vaccine’s safety and ability to boost individuals’ immune response against H5N1. Tested
vaccines are made from inactivated (killed) H5N1 virus. Different dose levels are being studied. Volunteers are to
receive two vaccinations approximately three weeks apart. The studies will allow GSK to select an optimal dose and
formulation for subsequent safety trials in groups at high risk of complications following influenza infection, such as
children and the elderly.
Preliminary results from the clinical trials are expected in the third quarter of 2006. GSK plans to have a pandemic flu
vaccine in production before the end of the year.
Jean Stéphenne, President of GSK Biologicals, the vaccine division of GSK, said: “We are moving forward with clinical
trials of vaccines which could prove a vital part of the world’s response to a flu pandemic. While the first vaccine
candidate aims at mounting a strong defence against a pandemic outbreak, the second vaccine may offer governments a
preferred option to proactively stockpile and begin vaccination before the onset of a pandemic, significantly increasing
the speed of a public health response in the event of an outbreak.”
Emmanuel Hanon, GSK head of Flu operations worldwide, said: “We believe that vaccinating populations with the
appropriate H5N1 vaccine will help educate the body’s immune system and reduce expected morbidity and mortality
associated with a pandemic. This means that if the current bird flu virus mutates to allow human-to-human transmission,
a vaccinated person will be better prepared to combat the H5N1 pandemic flu virus.”
H5N1 avian influenza infections lead to severe disease in both birds and humans. Public health experts fear that the
virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic. Influenza
pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu
virus strain.
GlaxoSmithKline, a leader in Flu treatment and preparedness
GlaxoSmithKline has an active research and development programme targeted at both seasonal and pandemic influenza and
has recently committed over one billion pounds ($NZ2.96 billion) to expand capacity for manufacturing flu vaccine and
its anti-viral influenza treatment Relenza® (zanamivir for inhalation).
GSK was the first company to submit a “mock-up” dossier for a pandemic vaccine with traditional alum adjuvant to
European regulators in December 2005. Under new European rules, the vaccine was given accelerated review status. Should
a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid
registration and production of a pandemic vaccine more closely matched to the circulating pandemic strain.
In North America, GSK recently acquired a major influenza vaccine manufacturer, ID Biomedical Corporation. This
acquisition provides GSK with a significant increase in flu vaccine manufacturing capacity. The production capacity of
the newly acquired Canadian facilities - combined with GSK’s expanded vaccines manufacturing plant in Dresden, Germany -
is expected to reach around 150 million doses per year by 2008. These numbers are based on production of trivalent
seasonal influenza vaccine. The production capacity of a monovalent flu pandemic influenza vaccine can be expected to be
significantly higher.
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline
is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For
company information visit: www.gsk.co.nz or www.gsk.com.
ENDS