DURHAM – Could the end to seasonal flu shots be in sight? Possibly, if Duke researchers have their way.
The Duke Human Vaccine Institute (DHVI) landed multiple contracts totaling up to $400 million over seven years from the National Institute of Allergy and Infectious Diseases (NIAID) to overhaul the flu vaccine, it was announced today.
It’s all part of a national drive by the NIAID to develop a longer-lasting, more broadly protective vaccine to replace the seasonal flu shot.
If the options on all three contracts are exercised, it would be the largest federal multi-contract award supporting one program in Duke’s history.
“The [DHVI] has long been a global leader in the research and development of lifesaving vaccines, and these extraordinary contracts will strengthen the institute’s efforts to develop innovative solutions to one of the most pervasive and intractable health challenges we face today,” Duke University President Vincent E. Price said in a statement.
Duke Human Vaccine Institute GMP manufacturing facility. Credit: Shawn Rocco
Current flu vaccines do not protect against all varieties of the virus. As such, new formulations based on predictions of what is likely to be circulating during flu season are required each year.
Officials say a more universally protective vaccine could cut the toll of influenza, which kills 300,000 to 500,000 people worldwide each year and causes up to 5 million cases of severe infection that often result in costly hospitalizations.
Duke is the only institution to receive a contract in each of the three CIVICs components. They include: designing and evaluating influenza vaccine approaches, manufacturing and evaluating the safety and toxicity of vaccine platforms, and conducting clinical trials for influenza vaccines.
The first contract involving vaccine development, $7.9 million in first-year funding with up to $107.5 million over seven years, involves conducting basic immunology and virology research to identify potential vaccine candidates.
Dr. M. Anthony Moody, associate professor in the departments of Pediatrics and Immunology at Duke School of Medicine, who is leading this project, said some of this work has already been done, and candidates are already in contention. For this portion, Duke’s contract encompasses collaborative work with Boston Children’s Hospital, Ragon Institute of MGH, MIT and Harvard, the University of Pennsylvania and the University of Texas.
The second contract, $13.8 million in first-year funding and valued up to $116.7 million over seven years if all options are exercised, is for vaccine manufacturing and will be led by Matthew R. Johnson, Ph.D., senior director of product development at the DHVI.
The third contract for the DHVI, $7.9 million in first-year funding and valued at up to $176.6 million over seven years if all options are exercised, provides funding for clinical trials that test the vaccine candidates developed through the CIVICs program. Duke is one of two centers receiving contracts to run the clinical trials.
The principal investigator for the clinical trials contract is Emmanuel “Chip” Walter, M.D., a professor in the Department of Pediatrics at Duke University School of Medicine and chief medical officer of the DHVI. This phase will test promising vaccines in small groups of healthy adult participants.
Successful vaccine candidates may eventually be advanced to larger clinical trials and human challenge studies in healthy adults and people at high risk of the most serious complications of flu, including children, pregnant women and older adults.
“We have broad range of investigators and expertise that has placed the DHVI on the forefront of vaccine development,” Walter said in a statement, citing both the center’s track record in HIV vaccine development as well as for flu. Responding to the 2009 pandemic flu, he said, the DHVI team was involved in testing a vaccine before it was used in the broader population.
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