News

A city of Rochester man who was enrolled in a clinical trial at the VTEU for the antiviral drug, Remdesivir, has recovered from COVID-19 after spending 25 days at Strong Memorial Hospital. The URMC has been participating in an NIH-sponsored clinical trial to evaluate the safety and efficacy of the investigational drug. The study is led by Ann Falsey, M.D. and Angela Branche, M.D. Read the full story.

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.

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 rghcovidvaccinetrial@rochesterregional.org.

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.

Angela Branche, M.D. and Ann Falsey, M.D., who are at the forefront of the national response, joined 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 was broadcast Thursday, April 23, 2020 from 8:00-9:00pm. Read more about this forum or view the recording of this forum.

The University of Rochester Medical Center (URMC) have launched a new study to understand how the body's immune system responds to COVID-19, including if and when a person could be re-infected with the virus and whether some people have pre-existing immunity. The findings could have significant implications for the public health response to the pandemic, the development of COVID-19 vaccines, and decisions related to re-opening the economy and society.

This study was featured on 13WHAM.

The new coronavirus research is being led by David Topham, Ph.D., Angela Branche, M.D., and Ann Falsey, M.D., under the URMC New York Influenza Center of Excellence(NYICE), one of the five international centers in the Centers of Excellence in Influenza Research and Surveillance network. The research is supported by approximately $5 million in funding from the National Institute of Allergy and Infectious Diseases (NIAID), the institute headed by Anthony Fauci, M.D.

"This research will seek to answer several important questions, including the durability of immunity from the virus once a person has been infected and recovered, whether the virus is mutating, whether previous exposure to other seasonal coronaviruses provides a degree of protection from COVID-19, and how long potential vaccines could provide immunity from the virus," said Topham.

The study will recruit up to 100 COVID-19 positive individuals across all age groups from the Rochester community and follow them for 90 days. The researchers will collect samples that will enable them to isolate and study the virus, and measure immune response to the infection.

Specifically, it will track the production of antibodies that seek out and flag the virus for destruction by immune cells. Once produced in sufficient quantity, these antibodies and other cells generated by the immune system provide protection from re-infection. These cells are also activated after vaccination. However, as is the case with other viral infections such as the flu, it is speculated that immunity to COVID-19 will weaken over time.

This research builds on more than a decade of influenza and respiratory pathogens research by the NYICE. For the past 13 years, URMC researchers have been conducting surveillance studies in an effort to better understand the immune response to the flu and vaccination. At the request of NIAID, URMC researchers have retooled and expanded the influenza study to include on COVID-19.

The University of Rochester Medical Center (URMC) is participating in a NIH-sponsored clinical trial to evaluate the safety and efficacy of the investigational antiviral drug remdesivir in hospitalized adults diagnosed with COVID-19. The study is being led by Ann R. Falsey, M.D., and Angela R. Branche, M.D., with the URMC Vaccine and Treatment and Evaluation Unit (VTEU).

Remdesivir, developed by Gilead Sciences, is a broad-spectrum antiviral treatment that has been previously tested in humans with the Ebola virus and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses. It is believed that the drug blocks a particular enzyme that is required for viral replication.

The double-blind, placebo-controlled trial will involve acute COVID-19 inpatients at Strong Memorial Hospital. The study may be expanded over time to include additional investigational antiviral treatments.

The URMC VTEU was established with support from the National Institute of Allergy and Infectious Diseases to conduct clinical trials of vaccines, treatments, and diagnostics for known and emergent infectious threats. URMC is one of only nine VTEU sites in the U.S.

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.