Five different vaccines for clinical trials aimed at protecting against the virus 09 H1N1 influenza will begin soon in the US, the National Institute of allergy and infectious Diseases US (NIAID) announced today. The tests, held in eight university clinics and non-profit organizations across the country, will recruit up to 3150 participants of different ages and test new vaccines made by Sanofi-Pasteur and CSL Biotherapies.
The tests will evaluate two dose vaccines and also if adding a second shot is needed to induce an immune response strong enough. They will also discuss whether the new vaccine that protects against seasonal influenza interact with each other, whether immune responses change if the products are given together or if given a few weeks apart. None of the vaccines in these studies contain adjuvants, immune system boosters that are not included in the vaccines against influenza approved by the Food and Drug Administration of the United States, but are approved for use in many other countries.
The US government purchased vaccine ingredients, including additives worth nearly $ 3 billion, and hope to have products ready in the fall. NIAID said the data from these clinical trials will provide crucial information on safety and effectiveness. "These data will be factored into the decision about how and whether the implementation of a vaccination program against H1N1 flu this fall 09," said NIAID Director Anthony Fauci in a prepared statement.
Meanwhile, Australia has begun the first clinical trials of a new vaccine H1N1 yesterday by Melbourne-based CSL Limited (the parent company of CSL Biotherapies). It would involve 240 people.
0 Komentar