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Cincinnati Children’s to Begin Testing H7N9 Avian Influenza Vaccine Candidate

Wednesday, September 18, 2013

Cincinnati Children’s Hospital Medical Center is one of nine centers nationwide taking part in clinical trials testing in humans an investigational H7N9 avian influenza vaccine.

The two concurrent Phase II clinical trials, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are designed to gather critical information about the safety of the candidate vaccine and the immune system responses it induces when administered at different dosages and with or without adjuvants, substances designed to boost the body’s immune response to vaccination.

Cincinnati Children’s is participating in the studies as one of just eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States. A ninth center is serving as a subcontractor.

Human cases of H7N9 influenza first emerged in China in February 2013, with the majority of reported infections occurring in the spring. As of August 12, 135 confirmed human cases, including 44 deaths, have been reported by the World Health Organization. Most of these cases involved people who came into contact with infected poultry. Although no H7N9 influenza cases have been reported outside of China, and the virus has not demonstrated sustained person-to-person transmission, there is concern that it could mutate to pose a much greater public health threat.

“Although the virus has not been detected in the United States and is not easily spread between people, we are concerned the virus might change so that it spreads rapidly,” says David Bernstein, MD, an infectious diseases physician leading the studies at Cincinnati Children’s.  “Therefore, we need to be prepared with a vaccine to protect people; we’d rather be safe than sorry.”

The two clinical trials, which will enroll healthy adults ages 19 to 64, will evaluate an investigational H7N9 vaccine developed by Sanofi Pasteur. The candidate vaccine was 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 two doses of vaccine without adjuvant may not produce an immune response adequate to provide effective protection.

In pandemic situations, adjuvants also can be used as part of a “dose-sparing” strategy, which would allow production of more doses of vaccine from the available supply of the viral antigen, thereby allowing a greater number of people to be vaccinated more quickly.

In both studies, which are expected to conclude in December 2014, a panel of independent experts will closely monitor safety data at regular intervals throughout the trial.

The vaccine studies are being conducted at the eight NIAID-funded Vaccine and Treatment Evaluation Units: Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. Additionally, the University of Texas Medical Branch at Galveston will be conducting the trial as a subcontractor to Baylor College of Medicine. 

Further information about both clinical trials can be found at ClinicalTrials.gov using the identifiers: NCT01938742 and NCT01942265.

Individuals interested in learning more about participating in the studies at Cincinnati Children’s can call the study line at 513-636-7699 or email gambleprogram@cchmc.org.

About Cincinnati Children’s

Cincinnati Children’s Hospital Medical Center ranks third in the nation among all Honor Roll hospitals in U.S.News and World Report’s 2013 Best Children’s Hospitals ranking. It is ranked #1 for cancer and in the top 10 for nine of 10 pediatric specialties. Cincinnati Children’s is one of the top two recipients of pediatric research grants from the National Institutes of Health, and a research and teaching affiliate of the University of Cincinnati College of Medicine. The medical center is internationally recognized for improving child health and transforming delivery of care through fully integrated, globally recognized research, education and innovation. Additional information can be found at www.cincinnatichildrens.org. Connect on the Cincinnati Children’s blog, via Facebook and on Twitter.