The last pandemic occurred in 2009 with the spread of H1N1 influenza, which originated in pigs and spread to people.
The clinical trial is designed to gather critical information about the safety and effectiveness of the vaccine and immune system responses it induces at different dosages, with and without adjuvantssubstances designed to boost the body's immune response to vaccination.
Two concurrent Phase II clinical trials will enroll healthy adults, ages 19 to 64 years old, to evaluate an investigational H7N9 vaccine. The candidate vaccine is made from inactivated H7N9 virus isolated in Shanghai, China, in 2013. Adjuvants are being tested with the investigational vaccine because previous vaccine research involving other H7 influenza viruses has suggested that vaccine without an adjuvant may not induce an adequate protective immune response.
A panel of independent experts will closely monitor participant safety data at regular intervals throughout the study.
"Whether or not an H7N9 pandemic materializes, vaccine studies such as this provide important experience in ongoing efforts to protect the public against sometimes-deadly influenza viruses," says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and Dean of the University of Maryland School of Medicine. "University of Maryland School of Medicine faculty researchers have been part of every similar vaccine study in the last few decades, making significant contributions to preparing the nation for emerging public health threats."
The University of Maryland is one of eight NIAID-
|Contact: Bill Seiler|
University of Maryland Medical Center