Duke CIVICs clinical activities will be coordinated through the Duke Vaccine and Trials Unit (DVTU) – the clinical trials arm of the DHVI. The DVTU serves as the site for screening and follow-up for Phase I and Phase II vaccine studies.
Duke CIVICs investigators have decades of investigative experience having enrolled over 7,400 participants in 112 different Phase I, II, III, and IV trials for a wide range of vaccine immunogens. Study populations have spanned the generations from infants to elderly and have included evaluations in pregnant women, preterm infants, asthmatics, and HIV-infected persons. Among study sponsors are the NIH, CDC, industry, and foundations. All unit work is conducted in a fashion to meet or exceed compliance with regulatory requirements and GCP. Since 2006, the DVTU has enrolled participants in over 16 VTEU pandemic influenza vaccine studies. Many of these investigations have included Phase I/II investigations of novel influenza vaccine virus vaccines both with and without adjuvants. Of particular note was Duke’s participation in the 2009 H1N1 pandemic influenza vaccine studies, which required rapid enrollment and evaluation of participants.