The National Institute of Allergy and Infectious Diseases is sponsoring a vaccine research project aimed at protecting humans from the H7N9 avian influenza virus and helping prepare the world for a global pandemic. Research will be done at eight sites across the U.S.
Participating institutions include the University of Maryland, Baylor College of Medicine, Children's Hospital Medical Center of Cincinnati, Group Health Cooperative of Seattle, St. Louis University, University of Iowa, Emory University, Vanderbilt University and the University of Texas Medical Branch in Galveston.
While no H7N9 bird flu cases have been reported in the U.S., the virus is susceptible to change and could lead to a global H7N9 pandemic, according to the University of Maryland's co-principal investigator, Dr. James D. Campbell. "There's genetic evidence this virus is mutating toward the possibility of sustained human-to-human transmission," Campbell said.
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 adjuvants - substances 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 the 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 a 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.