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 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,” said Kawsar Talaat, MD, principal investigator of the study and assistant scientist in the Bloomberg School’s Department of International Health.
The new H1N1 influenza strain was first described in April 2009 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 (WHO) 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. 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.
The trial will be conducted through the Bloomberg School’s Center for Immunization Research. Vaccinations are set to begin August 25. The trial is funded by CSL Biotherapies.
“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.
Media contact for Johns Hopkins Bloomberg School of Public Health: Tim Parsons at 410-955-7619 or tmparson@jhsph.edu.