News and Events
From the Division
Medical Center Launches Clinical Trials to Test Hydroxychloroquine in COVID-19 Patients
June 3, 2020
Medical Center researchers, led by Michael Keefer, M.D., professor and interim chief of Infectious Diseases, are joining a pair of new national clinical trials this week that will test whether hydroxychloroquine, an FDA-approved anti-malarial drug, can keep COVID-19 patients alive and out of the hospital.
While the drug has been widely touted as a potential treatment for COVID-19, results from coronavirus research studies reported thus far have been contradictory and inconclusive. These new randomized, controlled trials—which are sponsored separately by the National Institute of Allergy and Infectious Diseases and the Novartis pharmaceutical company—are designed to provide clear and conclusive evidence that can guide future treatment of COVID-19 patients. Rochester is one of approximately 25 sites in the AIDS Clinical Trials Group that are conducting the outpatient trial of the drug and one of 20 sites across the US conducting the inpatient trial.
Read the full story.
Dr. Angela Branche Discusses Impact of COVID-19 on Minority Communities
May 29, 2020
Infectious Diseases expert Angela Branche, M.D., shared her take on COVID-19's impact on communities of color with the Minority Reporter (May 12). Branche, who is involved in a study of a potential treatment for COVID-19, said COVID-19 is moving like a "tornado" through minority communities. In the interview, she discusses the factors that have led to a disproportionate number of hospitalizations among minority populations.
WXXI Interviews Brenda Tesini and Other Experts about New COVID-19 Linked Syndrome in Children
May 14, 2020
Brenda Tesini, M.D. helps explain Pediatric Multisystem Inflammatory Syndrome (PMIS), a new illness appearing in children who have had COVID-19, in an interview with WXXI News. URMC doctors are working with federal and state agencies to document and identify all the symptoms of PMIS.
Ann Falsey Speaks with News 8 TV about Remdesivir Therapeutic Trial and other Studies
May 8, 2020
Ann Falsey, M.D. spoke with News 8 to share her expertise and describe current research projects at URMC’s VTEU investigating potential treatments for COVID-19. Current studies include the second phase of the national NIH-sponsored trial of Remdesivir, which is now a standard of care. Watch the interview.
URMC, RRH Collaborating to Test Experimental Coronavirus Vaccine
May 5, 2020
The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) are investigating a new potential coronavirus vaccine developed by Pfizer and BioNTech.
“COVID-19 is a highly infectious and deadly disease and there is a tremendous urgency to develop a vaccine that will help us fight this global pandemic,” said Edward Walsh, M.D., a professor in the URMC Department of Medicine (Infectious Diseases) and member of the Infectious Diseases Unit at Rochester General Hospital. “While the scientific and medical community are moving at an unprecedented speed to advance vaccine candidates, it is critical that this effort be conducted in a rigorous manner that evaluates the safety and efficacy of potential vaccines. This new clinical trial is the first step in that process.”
Walsh and Ann R. Falsey, M.D., co-director of the URMC Vaccine Trials and Evaluation Unit and a member of the Infectious Disease at Rochester General Hospital, are leading the Rochester arm of the study.
The randomized placebo-controlled clinical trial will recruit 90 individuals in the Rochester area ages 18 to 85 who have not been infected with COVID-19 and will evaluate the safety, tolerability, and immunogenicity of up to four variations of the vaccine. Pfizer contracted with URMC to conduct the clinical trial in Rochester and the recruitment of study volunteers and testing of the vaccine will occur at Rochester General Hospital. The study is the only active COVID-19 vaccine clinical trial in upstate New York.
In March, Pfizer partnered with BioNTech, a German biotech company that has created a platform to rapidly develop vaccines for coronavirus and other emerging viral diseases. While there are approximately 100 potential COVID-19 vaccines in various stages of development, the Pfizer/BioNTech experimental vaccine is one of only seven that have advanced to human clinical trials worldwide. Rochester is one of four sites in the U.S. that will be conducting early stage studies of the vaccine, which began in clinical trials in Germany in late April.
Traditionally, effective vaccines against viruses like hepatitis A and B and influenza contain protein components of the virus called antigens to stimulate the immune system to produce antibodies and immune cells that provide protection from infection.
The Pfizer/BioNTech vaccines will utilize a relatively new genetic engineering method to stimulate the immune system to produce a protective response to the new coronavirus. The vaccines are composed of short sequences of the virus RNA, known as messenger RNA (mRNA), which provide precise instructions to the recipients own cells to produce the virus antigens. While experimental vaccines against cancer and bird flu have used a similar mRNA strategy, there are currently no approved RNA vaccines for humans.
Individuals interested in learning more about volunteering for the study should call (585) 922-5944 or email firstname.lastname@example.org.
Remdesivir Results “Promising” in Medical Center Clinical Trial
April 30, 2020
The University of Rochester Medical Center has been participating in a clinical trial testing the safety and efficacy of the antiviral drug Remdesivir. According to preliminary results released by the National Institutes of Health, the drug is now showing promise in treating adults diagnosed with COVID-19.
The study is led by Ann Falsey, M.D. and Angela Branche, M.D. with the Medical Center’s Vaccine Treatment and Evaluation Unit (VTEU). The Medical Center is one of only nine VTEU sites in the US.
“Based on some of the data that has come out in the last couple of days, it seems that Remdesivir does show some proven benefit over placebo,” Branche says.
Preliminary data from the trials indicate Remdesivir speeds up recovery time for some patients with COVID-19. Specifically, the data show that patients who received Remdesivir recovered, on average, four days faster than patients who received a placebo (11 days versus 14 days). The results also suggested a mortality rate of 8.0 percent for the group receiving Remdesivir versus 11.6 percent for those in the placebo group. That result is considered promising but not statistically significant.
Sixteen COVID-19-positive volunteers from the University’s Strong Memorial Hospital were enrolled in the double-blind, placebo-controlled trial and received either placebo or the drug, administered intravenously.
The trial is ongoing and more information will be forthcoming, including how best to use the drug and whether its effectiveness can be improved by administering it in conjunction with other drugs, such as the anti-inflammatory baricitinib.
“The results with Remdesivir are positive, but it’s not a miracle drug,” Falsey says. “It becomes our building block on which we try to improve.”
Read more about the NIH-Sponsored Study.
Dr. Falsey and Branche to be featured on WXXI Live Forum: Fighting COVID-19
April 21, 2020
Angela Branche, M.D. and Ann Falsey, M.D., who are at the forefront of the national response, will join a panel of medical researchers and experts in a virtual forum hosted by WXXI-TV to discuss what we know about how COVID-19 is spreading, how the body responds to the infection, and what is being done to develop new treatments and vaccines.
The forum is scheduled to be broadcast Thursday, April 23, 2020 from 8:00-9:00 pm. Read more about this forum.
Researchers Awarded $4.3 Million to Conduct Infectious Disease Vaccine, Treatment Trials at URMC
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-Wiltse, 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.
Marguerite Urban Receives 2019 Dr. Linda Laubenstein Clinical Excellence Award
December 17, 2019
Marguerite Urban, M.D. was recognized by The New York State Department of Health AIDS Institute with the 2019 Linda Laubenstein Award for her leadership and continuing commitment to expanding awareness of HIV medicine and prevention among care providers throughout New York. Dr. Urban has cared for patients with HIV at the UR AIDS Center, served on HIV/STI related-NYSDOH AI guideline committees, conducted research as a co-investigator for NIH-funded clinical trials related to HIV/STI prevention, and has provided extensive clinical education and training regarding sexual health and HIV/STIs throughout New York and nationally. Dr. Urban currently directs the NYSDOH Clinical Education Initiative (CEI) Sexual Health Center of Excellence and continues to serve as the Medical Director of the Monroe County STD Clinic, a position she has held since 1994.
Research Led by Ghinwa Dumyati Sparks New Federal Guidance for Doctors
July 10, 2019
Ghinwa Dumyati, M.D., Director of the Communicable Diseases Surveillance and Prevention Program at the Center for Community Health and Prevention, began tracking bacterial and fungal infections among intravenous drug users two years ago when she noticed a sharp increase in these infections in this population and reported her findings to the Centers for Disease Control. As a result of her research, a new guideline for medical health professionals was issued regarding the risk factors for infection when injecting drugs in a non-prescribed way. Dr. Dumyati was interviewed by WXXI News about her research; see the article posted on their website.
AAP Taps Mary Caserta for Infectious Diseases Committee
July 10, 2019
Mary Caserta, M.D., professor of Pediatrics, was selected by the American Academy of Pediatrics to serve a six-year term on its Committee on Infectious Diseases effective July 1. Caserta is a faculty member in the Division of Pediatric Infectious Diseases and is Director of the Pediatric Infectious Diseases Fellowship.
The Committee on Infectious Diseases monitors current developments in the prevention, diagnosis, and treatment of infectious diseases and reports these to the membership and broader medical community with recommendations and policy statements. It also prepares updated editions of the Red Book: Report of the Committee on Infectious Diseases, recognized as the leading source of information and guidance for practicing pediatricians.
Ann Falsey & Thomas Mariani Secure $3.8M NIH Grant to Reduce Antibiotic Overuse
February 19, 2019
Ann R. Falsey, M.D., professor of Infectious Diseases, and Thomas J. Mariani, Ph.D., professor of Pediatrics, received a 5-year, $3.8 million grant from the National Institutes of Health to search for a better way to distinguish bacterial and viral respiratory infections. The goal of the study is to define predictive genes – using gene expression profiling of blood – that can be developed into a simple point of care diagnostic that can be used by clinicians to discriminate bacterial and non-bacterial illness. Such a test would allow physicians to optimally manage patients with acute respiratory infections, which are a leading cause of antibiotic overuse and are linked to the rise of antibiotic resistant organisms.
The grant is the result of research done as part of the NIH-funded Respiratory Pathogens Research Center. Falsey and Mariani are the co-principal investigators, and Edward Walsh, M.D., Angela Branche, M.D. and Derick Peterson, Ph.D. are co-investigators.
From the Press Room