Five clinical trials of different vaccines that aim to protect against the 2009 H1N1 influenza virus will soon begin in the United States, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced today. The tests, held at eight academic and nonprofit clinics across the country, will recruit up to 3150 participants of different ages and test the new vaccines made by Sanofi-Pasteur and CSL Biotherapies.
The trials will evaluate the vaccines at two doses and also whether adding a second shot is needed to induce a strong enough immune response. They also will address whether the novel vaccine and the one that protects against seasonal flu interact with each other, assessing whether immune responses change if the products are given together or if they are given a few weeks apart. None of the vaccines in these studies will contain adjuvants, immune system boosters that are not included in any influenza vaccines licensed by the U.S. Food and Drug Administration, but are approved for use in many other countries.
The U.S. government has purchased nearly $3 billion worth of vaccine ingredients, including adjuvants, and hopes to have products ready in the fall. NIAID says data from these clinical trials will provide crucial information about safety and efficacy. "These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall,” said NIAID Director Anthony Fauci in a prepared statement.
Meanwhile, Australia began the first clinical trials of a novel H1N1 vaccine yesterday, made by Melbourne-based CSL Limited (the parent of CSL Biotherapies). It will reportedly involve 240 people.