GlaxoSmithKline begins human trial program with two H5N1 pandemic flu vaccines

By E. Janene Geiss

Philadelphia, March 30 - GlaxoSmithKline said Thursday it started an international clinical trial program 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 options to face threats of a pandemic, according to a company news release.

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 GlaxoSmithKline submitted to European regulators in December 2005. Should a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid European registration and production of a pandemic vaccine, officials said.

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.

GlaxoSmithKline said it 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.

The company's novel adjuvant technology also is 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, officials said.

Both trials are testing the vaccine's safety and ability to boost individuals' immune response against H5N1. Tested vaccines are made from inactivated H5N1 virus. Different dose levels are being studied.

Volunteers are to receive two vaccinations about three weeks apart.

The studies will allow the company 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. GlaxoSmithKline said it plans to have a pandemic flu vaccine in production before the end of the year.

"While the first vaccine candidate aims at mounting a strong defense 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," Jean Stephenne, president of GlaxoSmithKline Biologicals, the company's vaccine division, said in the release.

Company officials said 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 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, officials added.

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.

GlaxoSmithKline, a London research-based pharmaceutical and health care company, has an active research and development program targeted at both seasonal and pandemic influenza and has recently committed more than $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza (zanamivir for inhalation).

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