Infectious Diseases Research Clinic
The Infectious Diseases Research Clinic is located in the University of Rochester Medical Center in Rochester, NY. This clinic designs and conducts vaccine studies to prevent many different diseases that affect humans. Previous vaccine studies have included investigational vaccines to protect against seasonal pandemic and avian flu, pneumococcal disease, anthrax, herpes, malaria, human papillomavirus (HPV), and smallpox.
The clinic also operates an inpatient facility at St. Mary’s Hospital in Rochester. The studies conducted at the inpatient facility focus on investigational vaccines and respiratory virus immunity. This clinic is directed by Dr. Angela Branche. The team includes nurses and research assistants who have many years of clinical research experience.
New York Influenza Center of Excellence - NYICE
Respiratory Pathogens Research Center - RPRC
UR Vaccine Treatment & Evaluation Unit (UR VTEU)
Researchers Awarded $4.3 Million to Conduct Infectious Disease Vaccine, Treatment Trials at UR VTEU
January 24, 2020
Ann Falsey, M.D.
Angela Branche, M.D.
Researchers at the University of Rochester Medical Center (URMC) were awarded $4.3 million from the National Institutes of Health to conduct clinical trials of vaccines, treatments and diagnostics for known and emergent infectious threats.
The seven year grant, led by co-principal investigators Ann R. Falsey, M.D., and Angela R. Branche, M.D., will establish a Vaccine and Treatment Evaluation Unit (VTEU) at URMC. The University is one of nine sites across the country to be named a VTEU, and will work closely with VTEUs at Emory University, University of Maryland, Vanderbilt University Medical Center and other sites to conduct a wide range of clinical studies.
URMC has a long history of testing vaccine candidates—from seasonal flu vaccines to smallpox and pandemic H1N1 vaccine candidates—as well as conducting human challenge trials, where healthy volunteers are isolated and exposed to infection and vaccination under tightly controlled conditions. Falsey and Branche will likely run one to two VTEU trials a year, with additional funds (above and beyond the $4.3 million) coming to the University to support implementation.
Leaders of the VTEUs will work with the National Institute of Allergy and Infectious Diseases at NIH to determine the areas of focus and prioritize projects for the consortium. One major focus will likely be the development and testing of a universal flu vaccine. Sexually transmitted diseases like gonorrhea and syphilis, which are spreading rapidly among certain populations in the U.S. and becoming resistant to current treatments, could be the subject of other diagnostic and treatment trials. The consortium will also be ready to respond to emerging disease threats (such as the recent Zika and Ebola outbreaks) with the rapid design and launch of clinical trials.
In addition to Branche, assistant professor of Medicine, and Falsey, professor of Medicine, several co-investigators will participate in the research:
- Mary T. Caserta, M.D., professor of Pediatrics, will focus on trials in children and pregnant women.
- Michael C. Keefer, M.D., professor of Medicine, and Catherine A. Bunce, senior associate of Medicine, will direct enrollment of high-risk populations.
- David J. Topham, Ph.D., professor of Microbiology and Immunology, will direct laboratory resources.
- Jeanne Holden-Wiltsie, M.P.H., M.B.A., senior associate of Biostatistics and Computational Biology, will lead data management.
The new grant will also fund a clinical trial tract for infectious disease fellows. Falsey and Branche plan to recruit junior faculty members and train them how to manage clinical trials, including developing protocols, navigating the institutional review board process, recruiting, interacting with and following study subjects over time, and reporting study results.
The VTEU will utilize the Infectious Diseases Research Clinic in the Infectious Diseases Division at URMC.