Research Areas at the Duke Vaccine and Trials Unit

CISA

Duke University is a member of the Centers for Disease Control and Prevention (CDC) sponsored Clinical Immunization Safety Assessment (CISA) Project. As part of the national network, Duke assists safety experts from the CDC’s Immunization Safety Office (ISO) in providing a comprehensive vaccine safety public health service to the nation. The mission of the CISA project is to improve understanding of adverse events following immunization (AEFI) at the individual-patient level. Project goals include: 1) serving as a vaccine safety resource for consultation on clinical vaccine safety issues; 2) developing strategies to assess individuals who may be at increased risk for AEFI; 3) conducting studies to identify risk factors and preventive strategies for AEFI, particularly in special populations. More specifically Duke assists with clinical case evaluation for US healthcare providers who have vaccine safety questions about a specific patient residing in the US and provides consultation that enhances understanding of vaccine safety issues and informs clinical and public health practices.

Clinical Core Co-Investigator

Led by Dr. Kenneth Schmader, Chief Division of Geriatrics in the Department of Medicine, the DVTU has conducted numerous studies in our older adult population.  

Dr. Schmader's primary area of research is herpes zoster and postherpetic neuralgia (PHN) and vaccines in older adults. He conducts pre-clinical, epidemiological and intervention studies of zoster and PHN, particularly with the zoster and influenza vaccines. He is involved with other adult vaccine development in older adults. With colleagues in the Division of Infectious Diseases, Dr. Schmader investigates other infections in older adults.

Another major research focus is adverse drug reactions, medication prescribing and pharmacoepidemiology in the elderly. The objective of the medication work is to reduce adverse drug reactions, improve inappropriate prescribing and determine drug use patterns in the elderly.

To date, the DVTU has conducted studies assessing novel vaccines, treatments, and post-licensure vaccine safety.

  • POPS SILVER Study: Dr. Schmader is leading a study to determine the population pharmacokinetics of piperacillin-tazobactam and meropenem across age ranges.
  • Clostridium difficile (C. diff): Dr. Schamder is the Duke lead for a study to assess the safety and efficacy of microbial restoration by enema with banked and thawed processed stool in individuals with one or more recurrences of C. diff associated disease.
  • H7N9 in Older Adults Study: Dr. Schmader led the Duke site in a study to assess the safety, reactogenicity, and immunogenicity of an adjuvanted monovalent inactivated avian influenza vaccine in older adults.  Furthur information about the trial can be found at clinicaltrials.gov.
  • FLUAD vs. Fluzone High-Dose Study: Dr. Schmader and Dr. Walter are leading a study to assess the safety and immunogenicity of adjuvanted versus high-dose inactivated flu vaccine in older adults. Further information about the trial can be found at clinicaltrials.gov.
Haywood Brown, MD Distinguished Professor of Women's Health
Led by Dr. Geeta Swamy, Senior Associate Dean for Regulatory Oversight & Research Initiatives in Clinical Research, the DVTU has conducted numerous studies in our maternal/fetal medicine department. Dr. Swamy provides strategic vision and oversight of the regulatory components of the Duke Human Research Protection Program and assists with the development of broad-based research initiatives and other activities to support Duke’s growing clinical research enterprise.

Dr. Swamy has dedicated her career to advancing research in women’s health and to mentoring faculty and trainees. She is an internationally recognized clinician-researcher, and an expert and nationally-recognized leader in the field of maternal immunization and vaccination in pregnancy. She currently serves as the Co-Principal Investigator for the NIH-NIAID Vaccine Treatment and Evaluation (VTEU) and CDC-funded Clinical Immunization Safety Assessment, and has published over 100 peer-reviewed manuscripts. Dr. Swamy has been the Director of the Duke Perinatal Research Center since 2010.

To date, the DVTU has conducted studies assessing novel vaccines, treatment and post-licensure vaccine safety. The current studies Dr. Swamy leads are below:

  • Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632: Dr. Swamy and Dr. Vern Juel are leading a study to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin BoNT/B poisoning in adults. Further information about the trial can be found at clinicaltrials.gov.
     
  • Safety and Efficacy of the RSV F Vaccine to Protect Infants via Maternal Immunization: Dr. Swamy is participating in a Phase 3 study to evaluate the safety and immunogenicity of Novavax RSV-F protein nanoparticle vaccine, with aluminum, in healthy pregnant women. This study is international and will be enrolling 8,255 pregnant women. The study will also evaluate the levels of RSV serotype-specific antibodies in infants, and placental transfer from the pregnant women to the infant. Further information about the trial can be found at clinicaltrials.gov.
     
  • Safety of RIV4 versus IIV4 in Pregnant Women:  Dr. Swamy and Dr. Dotters-Katz are leading a study to evaluate the safety of Flublok®, the first recombinant inactivated influenza vaccine (RIV), and Flulaval, quadrivalent-inactivated influenza vaccine (IIV4), in pregnant women. This study will also evaluate adverse outcomes in infants, local and systemic reactogenicity, vaccine-related adverse events and immunogenicity following maternal RIV. 
Professor of Medicine
Led by Dr. Christopher Woods, Professor of Medicine, the DVTU has conducted numerous studies in our emerging infection/biomarkers department. Dr. Woods serves as Chief of Infectious Diseases and clinical microbiology, and hospital epidemiologist for the Durham VA Medical Center. Dr. Woods is board-certified in internal medicine, infectious diseases, and medical microbiology. His research focuses on the development of novel diagnostic approaches to infectious disease and the potential for interspecies transmission of pathogens. His genomic approach to harnessing the host response for diagnosis of infectious diseases has been called a paradigm shift in the field.
 
Dr. Woods is a partner in the Southeastern Center for Emerging Biological Threats, core PI of the Southeastern Research Center for Excellence on Emerging Infections and Biodefense, and a leader in the NIH-funded Vaccine and Therapeutics Evaluation Unit at Duke.
Chief Medical Officer, Professor of Pediatrics

Led by Dr. Emmanuel "Chip" Walter, Professor of Pediatrics, the DVTU has conducted numerous studies in our infant and adolescent population. Dr. Walter is the principal investigator for the Clinical Immunization Safety Assessment (CISA) Project at Duke and the co-principal investigator for the NIAID-sponsored Vaccine and Treatment Evaluation Unit (VTEU) at Duke. Although much of Dr. Walter’s early research career was focused on pediatric HIV infection, Dr. Walter has a long standing clinical and research interest in immunization issues.  Either as a principal investigator or co-investigator he has been conducting clinical vaccine studies including Phase I, II, III and IV vaccine evaluations for over 20 years. He directs the Duke Vaccine and Trials Unit (DVTU), is a member of the Duke Human Vaccine Institute, and co-directs the Duke Primary Care Research Consortium at the Duke Clinical Research Institute.  Most recently he has published primarily in the field of vaccines with a particular emphasis on early childhood influenza immunization. Dr. Walter currently serves as a member for the CDC Advisory Committee on Immunization Practices. The current studies Dr. Walter leads are below:

  • Dr. Greenberg and Dr. Walter are leading a multicenter study to assess apnea following vaccination in premature infants receiving their standard of care two-month vaccinations. Furhtur informatiom about this study can be found at clinicaltrials.gov.
     
  • Dr. Walter and Dr. Greenberg are conducting a study to assess the population pharmacokinetics of moxifloxacin administered to children per clinical care.
     
  • Dr. Walter is leading the Duke site in a study to evaluate the safety of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) in children with asthma of varying levels of severity.  The study is multicenter and will be enrolling 300 children.  Subjects will be randomized to receive either LAIV4 or IIV4.
     
  • Dr. Walter is leading a study to assess the feasibility of using clinic-based interventions (Buzzy alone, music alone, or Buzzy and music together) to prevent post-vaccination presyncope in adolescents.The study is single site and enrolling 30 adolescents, 10-17 years of age. More information about the trial can be found at clinicaltrials.gov.
Professor of Pediatrics

Dr. Michael Smith, Associate Professor of Pediatrics, leads the DVTU's effort in antimicrobial stewardship at Duke and is a member of the antibacterial resistance leadership group (ARLG). Over the past few decades, rampant use of antibiotics has led to the development of numerous antibiotic resistant strains of bacteria. The ARLG and DVTU are dedicated to monitoring the overuse of antibiotics to help stave off the introduction of these antibiotic resistant strains and "superbugs". Dr Smith recently joined Duke in 2017 from the University of Louisville and is a key member of the DVTU. Since joining Duke, he has led protocol development on a study to assess the pharmacokinetics of plazomicin in children and has contributed heavily to a vaccine study assessing the safety and immunogenicity of an H7N9 influenza vaccine.

Several studies at Duke as a part of the VTEU Network have focused on reducing unnecessary exposure to antibiotics in sick populations.

  • The SCOUT CAP study is lead at Duke by Dr. Chip Walter with recruitment also occuring at University of Arkansas Medical Center and Norton Children's Hospital in Louisville. This study is aimed at evaluating short course vs standard course treatment of community acquired pneumonia (CAP) in children. More information about this study can be found at clinicaltrials.gov.
     
  • The TRAP study is lead by Dr. Ephraim Tsalik. This study is a targeted reduction of antibiotics using procalcitonin (PCT) in a study of azithromycin treatment in outpatient adults with suspected lower respiratory tract infection and a PCT level of less than or equal to 0.25 ng/mL. More information about this study can be found at clinicaltrials.gov.

Duke investigators are currently conducting a number of studies to assess vaccine safety in special populations and to evaluate potential strategies to prevent AEFI. The Duke Human Vaccine Institute (DHVI) plays a critical role by providing the necessary infrastructure to conduct laboratory assessments for Duke CISA activities.