UI Health Care researchers to test new flu vaccine

University of Iowa researchers will help test one of two new investigational vaccines to prevent infection with the deadly H7N9 influenza virus.

The Phase 2 studies are sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Researchers will test different dosages of the vaccine, called 2017 H7N9 IIV, as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine.

H7N9 is an avian (bird) influenza virus first reported in humans in 2013 in China. Since then, six waves of H7N9 infection have occurred in China, resulting in more than 1,500 human infections, according to the World Health Organization. No human cases of H7N9 influenza have been detected to date in the United States.

Currently, the virus does not spread easily from person to person. Instead, people typically become infected through direct exposure to infected poultry or contaminated environments.

“Our concern is that the virus could mutate and become easily transmissible between humans, possibly resulting in an influenza pandemic since most people have little or no immunity to this type of flu,” says Jack Stapleton, MD, a UI Health Care infectious disease specialist who is leading the UI’s participation in the trial. “H7N9 has a high mortality rate, leading to death in 39 percent of those who became infected.”

The two clinical trials will test the experimental 2017 H7N9 IIV vaccine developed by Sanofi Pasteur, based in Lyon, France. NIAID funded previous research on the earlier version of the vaccine. The new version of the vaccine candidate uses an inactivated form of H7N9 influenza virus collected in 2017, to increase the likelihood that the vaccine will provide immunity against a newly-evolved strain of H7N9 that is currently circulating.

During these clinical trials, some participants will receive an adjuvant, called AS03, along with the test vaccine, to determine if the adjuvant can boost the immune response to the vaccine. The adjuvant is produced by GSK Biologicals, based in Wavre, Belgium. Both clinical trials will be conducted by the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs).

For more information about the two clinical studies referenced in this press release, please see the Questions and Answers or visit ClinicalTrials.gov using the identifiers NCT03312231 and NCT03318315, respectively.