The Duke Vaccine Trial Unit (DVTU) mission is to conduct clinical investigations related to the control and prevention of infectious disease with overarching goals of furthering our understanding of vaccine immune responses and correlates of protection from infection and enhancing vaccine safety. The DVTU includes a consortium of Duke investigators across multiple disciplines including: pediatric and adult infectious diseases; obstetrics and gynecology; geriatrics; neurology; surgery; and family medicine and community health.
With nearly three decades of clinical research experience, the DVTU serves as the clinical trial arm of the Duke Human Vaccine Institute (DHVI). The unit has been consistently funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), industry partners, and others.
Currently the unit serves 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 focuses on evaluating promising next generation influenza vaccine candidates in Phase I and Phase I/II clinical trials and conducting human influenza challenge studies.
In recent years much of 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. The DVTU responded to both the 2009 H1N1 influenza pandemic and the current SARS-CoV-2 pandemic through its work on pivotal NIH and industry sponsored vaccine trials.
Since 2013 the unit has also worked 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. Our most recent work includes studies of SARS-CoV-2 vaccines in special populations.
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 a CDC-funded project to further understand and reduce disparities in vaccine coverage among rural adolescents in the South.
Chip Walter, M.D., M.P.H., Principal Investigator for Clinical Core
Kristen Gunnell, Program Manager
Lynn Harrington, Clinical Core Manager