Emory enrolls volunteers in NIH clinical trial testing H7N9 vaccine

Woodruff Health Sciences Center | March 15, 2018

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Holly Korschun
404-727-3990
hkorsch@emory.edu

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The clinical trial is one of two that will test the experimental H7N9 IIV vaccine developed by Sanofi Pasteur.

The Emory Vaccine Center will participate in a new National Institutes of Health clinical trial testing an experimental vaccine to prevent H7N9 influenza virus infection. The Phase 2 study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is conducted by the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs), which include the Emory Hope Clinic of the Emory Vaccine Center and Emory Children’s Center.

The clinical trial is one of two that will test the experimental H7N9 IIV vaccine developed by Sanofi Pasteur. NIAID funded research on an earlier version of the vaccine that was also conducted at Emory. The new version uses an inactivated form of H7N9 influenza virus collected in 2017, and scientists hope the change will increase the likelihood that the vaccine will provide immunity against a newly-evolved strain of H7N9 that is currently circulating.

Emory is one of several VTEU sites in the clinical trial led by Kaiser Permanente Washington Health Research Institute in Seattle, including sites in Iowa, Maryland, North Carolina and Washington. The study will test the vaccine candidate at different dosages, both with and without an adjuvant called AS03, to determine if the adjuvant can boost the immune response to the vaccine. The adjuvant is produced by GSK Biologicals. A second clinical trial at additional VTEU sites will test the H7N9 vaccine candidate with AS03 adjuvant in conjunction with a quadrivalent seasonal influenza 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. The virus does not spread easily from person to person; rather, people typically become infected through direct exposure to infected poultry or contaminated environments. However, if the virus mutates and becomes easily transmissible between humans, it could result in an influenza pandemic; few people have immunity to the virus. H7N9 has a mortality rate of 39 percent in human outbreaks.

“It’s critically important that we be prepared for the potential next influenza pandemic by conducting the vaccine clinical trial,” says Emory infectious disease specialist Nadine Rouphael, MD, principal investigator of the Emory section of the Kaiser-led clinical trial. “As one of the NIH VTEU units, Emory is pleased to play a role in this important national clinical trial.”

For more information about the two clinical studies, see ClinicalTrials.gov, using the identifiers NCT03312231 and NCT03318315.

Emory VTEU contract number: HHSN272201300018I
H7N9 contract: HHSN27200019   FY.2017.B8C12.0080