August 31, 2009
School of Public Health testing H1N1 flu vaccine
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 under way.
The trial is being conducted through the Bloomberg School’s Center for Immunization Research. Vaccinations began at the school on Aug. 25.
“The H1N1 pandemic has already had a significant impact on health and society in general. Those most at risk are 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,” said Kawsar Talaat, principal investigator of the vaccine trial and assistant scientist in the Bloomberg School’s Department of International Health.
Ruth Karron, a professor in the Bloomberg School’s Department of International Health and director of both the Center for Immunization Research and the Johns Hopkins Vaccine Initiative, is co-principal investigator of the vaccine study.
The new H1N1 influenza strain was first described in April and is easily transmissible from person to person. Unlike seasonal flu, most people are unlikely to have immunity to the new virus strain. On June 11, the World Health Organization declared that the spread of the new H1N1 strain met the criteria for an influenza pandemic.
The trial, a Phase II study, will measure the safety of and 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. Each group will receive two injections of vaccine three weeks apart. Researchers will sample the participants’ blood at three and six weeks after the first vaccination to check for antibodies for H1N1, which indicate an immune response to the vaccine. Also, participants will keep a diary of any symptoms or reactions following vaccination.
Said Karron, “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.”