The Duke Vaccine Trial Unit (DVTU) is a consortium of investigators committed to conducting clinical investigations related to the control and prevention of infectious disease with an overarching goal of furthering our understanding of vaccine immune responses and correlates of protection from infection. We have overarching goals of furthering our understanding of vaccine immune responses, correlates of protection from infection and enhancing vaccine safety.
The Duke Vaccine Trial Unit (DVTU) serves as the clinical trial arm of the Duke Human Vaccine Institute. The unit has nearly three decades of experience conducting clinical investigations related to the control and prevention of infectious diseases. Research activities have been funded by the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), industry partners, and others. The DVTU includes a broad range of Duke investigators across multiple disciplines including: pediatric and adult infectious diseases; obstetrics and gynecology; geriatrics; neurology; surgery; and family medicine and community health.
The unit was recently awarded funding as one of the Clinical Cores for the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovations Centers (CIVICs). As a CIVICS clinical core, unit work will focus on evaluating promising next generation influenza vaccine candidates in Phase I and Phase I/II clinical trials and human challenge studies.
Since 2002 the unit has conducted work as either a subcontract or prime site for NIAID’s Vaccine and Treatment Evaluation Units (VTEUs). The VTEUs conduct clinical trials of vaccines and treatments for infectious diseases. In recent years our work has focused on preparedness for pandemic influenza, early phase investigations of novel vaccine candidates, pharmacokinetic studies of antimicrobial agents and monoclonal antibodies, treatment trials for infectious diseases, and epidemiologic investigations.
Beginning in 2013 the unit initiated work as one of the CDC’s Clinical Immunization Safety Assessment (CISA) sites. CISA conducts studies to identify risk factors and preventive strategies for adverse events following immunization, particularly in special populations. Our CISA work has included studies to evaluate methods for preventing fever in young children and pre-syncope in adolescents following immunization. In addition, we have conducted or are currently working on trials examining the safety of currently licensed vaccines in special populations including pregnant women, preterm infants, and older adults.
A final component of our work is to further the understanding of factors related to vaccine uptake in certain populations. We are currently engaged in CDC-funded project to further understand and reduce disparities in vaccine coverage among rural adolescents.
Chip Walter, M.D., M.P.H., Principal Investigator for Clinical Core
Kristen Gunnell, Program Manager
Lynn Harrington, Clinical Core Manager