Our team runs a fully functioning unit for performing phase I and II vaccine trials and enteric challenge models at the Vaccine Testing Center (VTC). In general, the VTC focuses on the development of vaccines of importance to global health, including typhoid fever, Campylobacter infections, dengue virus infections, cholera, rotavirus and polio infections. In 2009, the VTC began a 10-year project with Johns Hopkins and the National Institutes of Health's Laboratory of Infectious Diseases to study new Dengue vaccines. Other collaborators have included biotech companies, the National Institutes of Health and the Department of Defense.
Our laboratories are outfitted for scaled-up clinical immunology and microbiology work. Our staff is trained in current Good Clinical Practices (GCP) according to FDA E9 specifications and the laboratory operates on Good Clinical Laboratory Practice (GCLP) principles. Laboratories have the capacity for performing the immunogenicity work for multi-site vaccine trials, including specimen processing and storage. We also have the flexibility to add study-specific assays needed for vaccine trials. A detailed description of available equipment is available upon request. Experienced technicians are trained to perform validated immunologic and microbiology assays including: ELISAs, ELISPOT/ ASC/ ALS assays, functional assays of opsonization, PCR, multi-parameter flow cytometry and cell sorting, cytokine analysis (Bioplex), confocal microscopy, plaque-based assays for viral pathogens, bacterial culturing, and inoculum preparation for challenge studies.
Infectious Disease Immunology
In addition to vaccine testing, the lab is interested in characterizing how the human host responds immunologically to clinically important infectious agents and vaccines. The goal of this work is to gain a better understanding of immunologic responses to vaccines as well as natural infections.
In 2015, with collaborators from the icddr,b in Dhaka, Bangladesh, the VTC expanded its work with the National Institutes of Health and Johns Hopkins University to perform a phase I/II clinical trial of the NIH's tetravalent dengue vaccine in Bangladesh.
Also in 2015, the VTC received two awards from the Bill and Melinda Gates Foundation to study Rotavirus Vaccine Correlates of Protection and to understand Rotavirus vaccine underperformance, as well as to develop challenge models to support the testing of vaccines and therapeutics against the Cryptosporidium infection.
In 2014, the VTC received funding from the Bill and Melinda Gates Foundation (with Johns Hopkins University) to study Dengue Vaccine Immunology and correlates of protection. This work follows up on our five-year "PROVIDE" study in Bangladesh.
For details about recruitment for ongoing studies see Volunteer for Research.
Beth Kirkpatrick, M.D.
Professor of Medicine
Director, Vaccine Testing Center