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Five Spanish hospitals in international phase III trial with H5N1 influenza pandemic vaccine

side effects that could appear, such as pain in the injection area or fever, frequent after any type of vaccination, will be noted. This study has been approved by the Ethics Committees of Clinical Research of the five hospitals and also by the Spanish Agency of Drugs and Health Products.

This vaccine is fractionated, since it only contains parts of the viral proteins which activate our immune system. Since no complete virus is administrated, it is impossible that this vaccine could cause influenza. The vaccine includes an adjuvant, similar to that used by GSK in the malaria vaccine that Hospital Clnic is testing in Mozambique, which enhances the immunogenic effects of the vaccine. The stimulation of the immune system caused by this adjuvant, has already proved successful as a part of a vaccine against conventional influenza, and permits to reduce the antigen concentration administered in each vaccination. In the hypothesis of a pandemic, we must take into account that it would be necessary to vaccinate a large amount of population, and the rhythm of production of vaccines is limited. The efforts are focused in the development of strategies for vaccine production. Last, this vaccine has been produced following the recommendations of the WHO, so that the H5N1 virus has been recombined with the H1N1 Puerto Rico strain of 1934. This strain is highly stable and promotes the development of vaccines in chicken embryo.

The nomenclature of the several influenza virus identifies the variant they contain of the two more important genes involved in the infection. The Haemaglutinin (H) gene is related with the infectiousness and the virulence of the virus, whereas the Neuraminidase (N) gene determines the ability of progression of the infection. Genetic material of the virus is highly variable and it is found as fractionated single-strained RNA. Small changes in the H and N genes create viruses which cause the frequent annual influenza epidemic. When a large
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Contact: lex Argem
aargemi@clinic.ub.es
34-93-227-5700
IDIBAPS - Institut d'Investigacions Biomdiques August Pi i Sunyer
4-May-2006


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