NIH expands vaccine clinical trial network

Over their 50-year history, the National Institutes of Health's (NIH) Vaccine and Treatment Evaluation Units (VTEUs) have shaped immunization policy by stepping up when industry can't--or won't--run trials. This week, NIH reiterated its belief in the model by expanding its network.

The contract renewals saw Duke Medicine join the 8 VTEUs NIH funded in the last round of deals, which it made back in 2007. While NIH has stuck with its existing VTEUs, it has asked them to expand their expertise and capabilities to meet the changing demands of vaccine clinical trials. International studies are expected to play a bigger role, as are new technologies.

"Future projects are likely to use molecular tools that are now available to design better vaccines and to unmask signals that lead to immunity, while avoiding side effects," Dr. Karen Kotloff, principal investigator at the University of Maryland VTEU, said. The Maryland VTEU has kept pace with NIH demands by tapping into expertise in other departments at the university, such as the Institute for Genome Sciences and the School of Pharmacy.

In return for their support, each VTEU could receive annual payments of up to $135 million over the next 7 years, although the exact amount will depend on what each research center does in any given year. The last round of VTEU deals gave each site $23.7 million over 7 years. The funding comes as NIH looks to the VTEUs to help prepare the U.S. for potential pandemics and other threats.

Last month 8 of the VTEUs were contracted to trial Sanofi's ($SNY) H7N9 vaccine in combination with adjuvants from GlaxoSmithKline ($GSK) and Novartis ($NVS). "Launching and obtaining results from such studies quickly is possible because the VTEUs have proved that they can rapidly enroll large numbers of participants," NIH's Dr. Anthony Fauci said. The VTEUs are recruiting up to 1,700 people to participate in the trial.

- read the NIH news
- check out Maryland VTEU's release
- here's Cincinnati Business Courier's take

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