Duke CIVICs Clinical Core

Clinical Core

Duke CIVICs clinical activities will be coordinated through the Duke Vaccine and Trials Unit (DVTU) – the clinical trials arm of the Duke Human Vaccine Institute (DHVI). The DVTU serves as the primary site for Phase I and Phase I/II CIVICs vaccine studies.

Duke CIVICs investigators have extensive investigative experience having enrolled over 7,700 participants in 115 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 persons with HIV infection. 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 numerous pandemic and seasonal influenza vaccine trials. Studies for pandemic preparedness have included Phase I/II investigations of novel avian or swine 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.

The Duke Vaccine Trials Unit

The Duke Human Vaccine Institute (DHVI) Accessioning Unit and Biorepository provides clinical trials support through accessioning, processing, and storage of research biospecimens. The Accessioning Unit is a shared resource that provides accessioning and processing and the biorepository serves as a biobank for samples collected in numerous NIH-funded programs including the DAIDS-funded Center for HIV/AIDS Vaccine Immunology (CHAVI), the DMID-funded Vaccine and Treatment Evaluation Unit (VTEU) and the DMID-funded Antibacterial Resistance Leadership Group (ARLG).

Challenge Unit

The Duke CIVICs program will be conducting controlled human influenza challenge studies to evaluate promising new influenza vaccine candidates. Challenge studies will be performed at the Duke Early Phase Research Unit (DEPRU). DEPRU is a state-of-the-art, industry standard, 30-bed confinement unit located within Duke Hospital. The unit was specifically designed for the conduct of early phase clinical trials including first in human studies and has served as a site for prior rhinovirus and influenza virus challenges. Additionally, DEPRU has five well-equipped outpatient examination rooms including one room for complete pulmonary function testing. Nutritional support services are on-site in addition to a biospecimen processing laboratory and a CLIA/COLA accredited laboratory equipped with hematology, chemistry, and urine analyzers and staffed with certified Medical Technologists. A 24 station Mortara 12-lead ECG telemetry system allows for continuous cardiac monitoring in the outpatient and inpatient setting.

Accessioning Unit/Biorepository

The Accessioning Unit and Biorepository serves as a central point for receipt, processing, storage and distribution of biomaterials from supported projects and has state of the art physical and electronic space. All samples are recorded in a computerized inventory system based on Frontier Science’s Laboratory Data Management System (LDMS) and the Accessioning Unit employs a workflow that ensures checks for compliance (IRB/IACUC) and executed material transfer agreements (MTA) prior to specimen release. The Accessioning Unit and Biorepository operates in a Good Clinical Laboratory Practice (GCLP) environment under oversight from Quality Assurance Duke Immunogenicity Immunology Programs (QADVIP). All Accessioning Unit and Biorepository staff that prepare materials for shipping are trained in International Air Transport Association (IATA) regulations.

All physical materials are stored in 4°C, -20°C, -80°C, and LN₂ cold storage units in the Biorepository and connected to an automated, web-accessible and auditable temperature monitoring system (Minus80 Monitoring). The Biorepository currently has two 4°C, and one -20°C, twenty-seven -80°C, and nineteen LN₂ cold storage units. The Biorepository cold storage units house 650,000 vials at 4°C, -20°C, and -80°C and 150,000 vials in LN₂. The Biorepository currently has the capability of adding 40,000 vials at 4°C, -20°C, and -80°C and 20,000 in LN₂.