Research

Dennis Alfred Clements, MD, emeritus
Pediatric vaccine trials

Samuel L. Katz, MD, emeritus
Pediatric vaccines, vaccine delivery in low resource settings

Ross E. McKinney, Jr., MD, emeritus
Treatment of pediatric HIV infection, ethics of clinical research and conflicts of interest

The expertise and state-of-the-art resources available for research in pediatric ID at Duke are considerable. Our division faculty are integrated into major research efforts across the institution, the country, and the globe. This includes direct connections with the Duke Division of Adult Infectious Diseases, comprised of 56 faculty including 8 transplant ID faculty – the most in the nation at one university. The research collaboration between adult and pediatric ID at Duke, including joint grants and conferences, is unique in the country and relates in part to the close proximity of these divisions. Brief summaries of several key affiliations are highlighted below, with many more research platforms throughout the university integrated with pediatric ID.

Duke Clinical and Translational Institute (DCTI) coordinates Duke’s Clinical & Translational Science Award (CTSA), which aims to transform how fundamental discoveries are moved from bench to bedside and accelerate improvements in medical care. 

Duke Clinical Research Institute (DCRI) is the world’s largest academic clinical research organization, with over 1,100 faculty and staff. The DCRI provides the infrastructure to design, initiate, conduct, and report interdisciplinary and collaborative clinical research to help understand human conditions, develop new therapies, and translate basic research findings into patient care. Over the course of 20 years, the DCRI has managed >3,500 studies in over 65 countries, enrolled >1.2 million patients in nearly 1,000 Phase I-IV trials and outcomes projects, and generated >10,000 peer-reviewed publications. Daniel K. Benjamin, Jr., MD, PhD, Deputy Executive Director of the DCRI, is a pediatric ID faculty member.

DCRI Early Phase Research Center uses applied pharmacometrics and FDA collaborations to support all phases of drug development, and provides specific training in clinical pharmacology design, initiation, conduct, and analyses. Michael Cohen-Wolkowiez, MD, PhD, former director of this unit, is a pediatric ID faculty member.

Duke Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases is the result of a $90M NIAID contract to provide infrastructure for Phase I studies of anti-infective agents over the next 10 years. Trainees participate in protocol development, clinical trials operations, study implementation, data analysis, and result reporting. Michael Cohen-Wolkowiez, MD, PhD is the lead investigator of this unit.

Pediatric Trials Network (PTN) is a $95M NICHD-funded consortium centered at Duke to study off-patent therapeutics in children that partners academic investigators and trial operations experts. Since 2010, the PTN has completed or is enrolling for 12 clinical trials and has 16 ongoing pharmacokinetic-pharmacodynamic analyses. Daniel K. Benjamin, Jr., MD, PhD, is the principal investigator for this consortium.

Department of Molecular Genetics and Microbiology serves as the administrative infrastructure for 4 research centers that bridge investigators with primary and secondary appointments in the department with other investigators throughout the medical center. The Center for Host Microbial Interactions (CHoMI) comprises investigators focused on fungal and bacterial microbial pathogens; the Center of RNA Biology brings together investigators interested in the structure, function, and synthesis of RNA; the Center for Virology provides a forum for investigators who are focused on both basic and applied aspects of virology, including vaccine development; and the Duke Microbiome Center (DMC) brings together investigators focused on microbial communities and their interactions, including the human microbiome and environmental niches. Several division faculty have secondary appointments in this department or are DMC faculty members.

Division of Quantitative Sciences supports clinical, translational, and basic research within the Department of Pediatrics through expertise in biostatistics, econometrics, and health services research to assist in experimental design, analyses, and extramural funding applications. Daniel K. Benjamin, Jr., MD, PhD, who was the founding division chief, and Michael Cohen-Wolkowiez, MD, PhD also have appointments in this division.

Duke Human Vaccine Institute (DHVI) plays an integral leadership role in the global HIV/AIDS vaccine enterprise and is a pioneer in emerging infections and biodefense research. Emmanuel "Chip" Walter, MD a pediatric ID faculty member, serves as the chief medical officer for the DHVI. 

Duke Vaccine and Trials Unit (DVTU) is one of nine Vaccine Treatment Evaluation Unit (VTEU) centers in the US studying new and improved vaccines and therapies against infectious diseases. The DVTU is also one of seven academic centers participating in the CDC’s Clinical Immunization Safety Assessment (CISA) project. Emmanuel B. Walter, MD, a pediatric ID faculty member, is the principal investigator of both the DVTU and the Duke CISA project.

Center for HIV AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) is a multi-national program that investigates the immunology of HIV with the aim of obtaining improved understanding of the roadblocks to HIV vaccine development. 

HIV Vaccine Research and Development (HIVRAD) is an NIAID-sponsored effort to develop HIV vaccine candidates using non-human primate models. 

Duke Center for AIDS Research (CFAR), Duke’s concentrated center for HIV research, includes Coleen Cunningham, MD, as the clinical core co-director. The Duke CFAR promotes collaboration in HIV-related research by supporting the scientific needs of the basic and clinical research community. 

Duke Global Health Institute (DGHI) was established as a university-wide institute to coordinate, support, and implement Duke’s interdisciplinary research, education, and service activities related to global health. DGHI is committed to developing and employing new models of education and research that engage international partners and find innovative solutions to global health challenges. Dennis Clements, MD, PhD, a pediatric ID faculty member., is a senior advisor for DGHI.

Duke-Kilimanjaro Collaboration is a clinical and research site in Moshi, Tanzania that is the result of a combined effort of the DGHI and the Departments of Medicine and Pediatrics. This site includes a laboratory research building (supported by the Bill and Melinda Gates Foundation) and an HIV care facility (supported by the Elizabeth Glaser Pediatric AIDS Foundation). The site operates under the leadership of Dorothy Dow, MD, a pediatric ID faculty member.

International Pediatric Fungal Network (IPFN) is an NIAID and NICHD-funded, multi-national, 54-site consortium housed at Duke to define the epidemiology, optimal diagnostic strategies, and best treatments to improve the outcomes of children with invasive fungal infections. William Steinbach, MD, chief of the Division of Pediatric Infectious Diseases, is the director of the IPFN.

Antibiotic Resistance Leadership Group (ARLG) is a multi-site consortium funded by a $78M NIAID grant that was designed to prioritize, design and execute clinical research that will reduce the public health threat of antibacterial resistance. Vance Fowler, MD, a Duke adult ID faculty member, is the overall national co-principal investigator of the ARLG.  Michael Cohen-Wolkowiez, MD, PhD and Daniel K. Benjamin, Jr., MD, PhD, faculty members in pediatric ID, lead the pediatric pharmacology arm of the ARLG.

Trial Innovation Network (TRIDENT) is structured to study how multi-site clinical trials of new drugs and therapies in children and adults can be conducted more rapidly and efficiently.  The network is led by Daniel K. Benjamin, Jr., MD, PhD, a faculty member in pediatric ID, and supported  by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).

Environmental Influences on Child Health Outcomes (ECHO) is a $116M NIH-funded consortium coordinated by Duke to understand the effects of a broad range of early environmental influences on child health and development. The network is led by Daniel K. Benjamin, Jr, MD, PhD, a faculty member in pediatric ID.

• Pharmacokinetics of anti-infectives in pediatrics
• Pediatric antimicrobial stewardship
• Antifungal treatment of pediatric invasive candidiasis
• Newer antifungal agents for invasive yeast and mold infections
• Immune responses to novel vaccines
• Evaluation of HIV vaccines in domestic as well as international settings 
• Impact of mental health on antiretroviral medication adherence during adolescence

• Molecular and cellular determinants of uropathogenic E. coli infection
• Evaluation of the pathogenic mechanisms of Aspergillus infection
• Discovery of novel antifungals
• ​Newer biomarkers for diagnosis of invasive candidiasis
• Microbiome influence on hematopoietic stem cell transplant recipients
• Microbiome influence on the risk of pneumonia in African infants
• Evaluation of maternal immune responses and protection against perinatal viral pathogens
• Evaluation of virus variants that are transmitted placentally and via breastfeeding
• Innate antiviral factors in breast milk
• Maternal HIV-1 and CMV vaccine development
• Infant HIV-1 vaccine development