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GlaxoSmithKline Starts Human Testing Of Two Bird-Flu Vaccines
posted by admin on 03/04/06

LONDON -- GlaxoSmithKline PLC said it has begun human testing of two potential vaccines against the H5N1 strain of bird flu with the aim of having a vaccine in production before the end of this year. 

Glaxo is testing one shot in 400 healthy volunteers in Germany, and the other in 400 healthy volunteers in Belgium. Both trials are evaluating the vaccines' safety and ability to boost a person's immune response against H5N1. Glaxo expects to have preliminary results from the trials in the third quarter. Regular seasonal flu shots don't protect people against H5N1. 

Several drug companies and teams of government researchers have been racing in recent months to develop a shot that would protect humans from H5N1, which has killed 105 people over the past two years. Health officials are worried that H5N1 could mutate into a strain that would pass easily among humans, sparking a pandemic. 

The antiviral medicines Tamiflu and Relenza have shown some effectiveness at treating the symptoms of bird flu but they don't prevent a person from getting infected as a vaccine would. 

The world has a limited number of vaccine-production facilities, so most scientists are trying to invent a vaccine that could be stretched to more doses by adding a special booster called an adjuvant. The serum Glaxo is testing in Germany contains a classic type of adjuvant. In Belgium, Glaxo is testing a vaccine with a newer type of adjuvant that it hopes will have two benefits. First, it hopes the adjuvant will help stretch the vaccine to an even greater number of doses than a regular adjuvant would. 

It also hopes the adjuvant will help protect people against a broader range of H5N1 strains. This is important because no one knows which exact form of H5N1 could emerge as the strain that causes a pandemic. If Glaxo can come up with a vaccine that protects against a wide range of virus strains, the shot could be given to people before a pandemic begins, Glaxo officials 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," Emmanuel Hanon, Glaxo's head of flu operations, said in a prepared statement. "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." 

Glaxo has already submitted a "mock-up" application to Europe's main medicines regulator seeking broad-brush approval for a pandemic vaccine. Glaxo says this early application will speed ultimate approval if a pandemic virus emerges and if Glaxo invents an effective serum. 

Write to Jeanne Whalen at jeanne.whalen@wsj.com

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