The Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health has been selected by CSL Biotherapies of Australia as the lead site to conduct tests for a vaccine against the new H1N1 influenza. The trial will vaccinate 1,300 adults from sites across the United States and is one of the largest H1N1 vaccine trials currently being conducted. The trial began in August 2009 at the Center for Immunization Research; enrolling 55 volunteers. Kawsar Talaat, MD, principal investigator of the study and assistant scientist in the Bloomberg School’s Department of International Health. said that “the H1N1 pandemic has already had a significant impact on health and society in general. Those most at risk include children, young adults and pregnant women, as well as people with underlying medical conditions. A safe, effective vaccine to protect those at highest risk is a public health priority.” The trial, a Phase II study, will measure the safety of an immune response to CSL’s H1N1 flu vaccine at three separate dosing levels. Two groups of participants will be enrolled in the trial: adults 18 to 64 and adults older than 65. Both groups will receive two injections of vaccine three weeks apart. Researchers will sample the participant’s blood at 3 and 6 weeks after the first vaccination to check for antibodies for H1N1, which indicate an immune response to the vaccine. Participants will also keep a diary of any symptoms or reactions following vaccination. “This trial will help assess the safety of this new H1N1 vaccine, and determine how well it evokes an immune response. By looking at the immune response to several different doses of H1N1 vaccine, this trial will help to determine the best dose to use in vaccination campaigns,” said Ruth Karron, MD, co-principal investigator of the vaccine study and professor and director of the Center for Immunization Research, and the Johns Hopkins Vaccine Initiative. Watch Video
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