September 20, 2013
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NIH tests influenza H7N9 vaccine

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The NIH is sponsoring two clinical trials to test an investigational vaccine for H7N9 infection in humans.

As of Aug. 12, there have been 135 laboratory-confirmed cases of human infection with H7N9, including 44 deaths, according to WHO.

"H7N9 avian influenza virus — like all novel influenza virus strains to which people have not been exposed — has the potential to cause widespread sickness and mortality," Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. "We are now testing a vaccine candidate with and without adjuvant in an effort to prepare for and, hopefully, protect against this possibility."

Anthony S. Fauci, MD 

Anthony S. Fauci

According to the NIH, researchers at nine sites across the United States will test the vaccine in adults aged 19 to 64 years. The candidate vaccine was developed this year from inactivated H7N9 virus isolated in Shanghai, China.

The first trial, led by Mark J. Mulligan, MD, of Emory University, will include 700 participants receiving two equivalent dosages of the candidate vaccine (3.75 mcg, 7.5 mcg, 15 mcg or 45 mcg) approximately 21 days apart. Participants will be randomly assigned to the MF59 adjuvant (Novartis) combined with the candidate vaccine.

The second trial, led by Lisa A. Jackson, MD, MPH, a senior investigator at Group Health Research Institute in Seattle, will include approximately 1,000 adult participants who will receive dosages equivalent to those in the first trial. Participants will receive vaccinations either with or without the AS03 (GlaxoSmithKline) and/or MF59 adjuvants.

Lisa A. Jackson, MD, MPH 

Lisa A. Jackson*

Both trials are expected to conclude in December 2014.

"While the virus has not been detected in the United States and is not easily spread between people, public health officials are concerned the virus might change to become very contagious between people, which could trigger a global outbreak," Jackson said in a press release. "Should that occur, we need to be prepared with a vaccine to protect people from illness."

*Photo courtesy of Group Health Research Institute.