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In the wake of the COVID vaccine roll out, Infectious Disease Division experts have spoken to the media about the vaccine's safety and efficacy. Division researchers were involved in the clinical trials for the Pfizer-BioNTech vaccine currently in distribution.

• Anne Falsey, M.D., Professor of Medicine, told to Spectrum News (Dec. 10) there's "no reason to think that there would be long-term side effects" of the COVID vaccine. Falsey was joined by a vaccine trial participant who expressed confidence in the process of creating new and effective vaccines.
• Angela Branche, M.D., Assistant Professor of Medicine, and Edward Walsh, M.D., Professor of Medicine, joined other URMC and Health Department experts in a live forum on WXXI TV (Dec. 17) to discuss "vaccine science, distributions plans, how to ensure vaccines reach underserved populations, [and] new COVID-19 treatments."

Monroe County Executive Adam Bello and Monroe County Commissioner of Public Health Dr. Michael Mendoza today announced the appointment of Center for Community Health & Prevention Director Nancy "Nana" Bennett, MD, MS, as Special Advisor to the Monroe County Commissioner of Public Health. In this role, Dr. Bennett will lead the Monroe County vaccination task force and spearhead Monroe County's COVID-19 vaccination planning and coordination efforts.

Congratulations to Andrew Dylag who was recently awarded a prestigious Catalyst Award from the American Lung Association to study how chronic low doses of oxygen at birth prime the lung to develop hyperreactive airways disease.

Congratulations to Dan Steiner for winning a Sayeeda Zain Fall travel award. Dan is planning to attend the SPIE Photonics West meeting, to be held at the Moscone Center, San Francisco, California, March 6-11, 2021, He states "I am excited to represent our department and present my work in San Francisco (virtually or otherwise) . Networking and reaching out to labs and PIs at this conference will help me learn more about the entrepreneurial side of science and how to develop my career after I defend." The Sayeeda Zain Travel Award honors the distinguished career and charitable life of Dr. Sayeeda Zain. The award is given in recognition of research excellence to support expenses associated with attendance at a scientific conference or corporate internship to gain practical experience. Dan Steiner is a Biophysics graduate student studying in Dr. Ben Miller's lab

The University of Rochester Medical Center's Infectious Diseases Division has partnered with the National Institutes of Health (NIH) to study HIV/AIDS for more than 30 years. Their efforts have been recognized with a new $18 million grant to continue conducting vaccine and treatment trials and engaging with communities affected by HIV.

The award also allows Rochester researchers to study other high-priority infectious diseases, including COVID-19. The team (pictured above) pivoted to study coronavirus vaccines and treatments over the past six months, contributing to the worldwide effort to bring safe and effective vaccines and therapies to market as quickly as possible.

"While creating a preventive HIV vaccine has been complex, our work has established approaches that are used for HIV and also contributed to the unprecedented speed at which coronavirus vaccines are being developed," said Michael C. Keefer, M.D., professor in the department of Medicine and interim chief of the Infectious Diseases Division. For example, vaccines using adenoviruses as carriers of HIV proteins have been used in HIV research for years, and that is one of the approaches being used in two of the actively enrolling COVID-19 vaccine efficacy trials (AstraZeneca and Janssen trials). Additionally, anti-HIV monoclonal neutralizing antibodies have been shown to be effective in preventing some HIV infections, and anti-coronavirus monoclonal antibodies have become an important strategy to treat patients with early-stage COVID-19.

The division received its first grant and became a part of the National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS Clinical Research Networks in 1987. Led by Keefer and Stephen Dewhurst, Ph.D., chair of the department of Microbiology and Immunology, as well as program director Catherine Bunce, the new grant will run for seven years and will be used to:

• Coordinate and execute high-quality HIV/AIDS vaccine and treatment trials that enroll participants from diverse populations.
• Engage with local communities to assess attitudes to clinical research and conduct educational outreach around research participation.
• Mentor and train the next generation of HIV/AIDS researchers.
• Advance HIV/AIDS research by providing scientific leadership and supporting NIAID's AIDS Clinical Trials Group (ACTG) and HIV Vaccine Trials Network (HVTN).
• Provide data and quality management, regulatory support, laboratory, pharmacy and other resources to effectively support HIV/AIDS clinical trials.
• Rapidly respond to emerging infectious diseases that require national attention and coordination.

Minsoo Kim, Ph.D was recognized recently with the Davey Award, an honor bestowed on University of Rochester/Wilmot Cancer Institute faculty members who have made outstanding contributions to cancer research.

Yarovinsky lab identified that IFN-γ production by innate lymphoid cells is indispensable for host resistance against intracellular infection via maintaining inflammatory dendritic cells at the site of infection. PLOS Pathogens, in press

Special congratulations to the first author, Américo H. López-Yglesias, who is now an Assistant Professor at Indiana University School of Medicine.

What are you and your institution currently working on regarding COVID-19?

The Topham Lab launched a coronavirus research study to understand how the immune system responds to acute COVID-19 infection, including how long immunity lasts once a person has been infected and recovered. We have evidence of pre-existing cross-reactive memory B cells and Original Antigenic Sin in infected subjects. We are also collaborating with researchers at New York University and University of Idaho to examine whether mothers can transmit COVID-19 through breast milk (they don't) and whether the breast milk itself has immunological properties against the disease (it does). Funded by the Bill and Melinda Gates Foundation and the NIH, the study could result in critical guidance for current and soon-to-be mothers. Physicians at URMC and Rochester Regional Health are investigating a new coronavirus vaccine developed by Pfizer and BioNTech. The URMC Vaccines and Treatments Evaluation Unit is testing Remdesivir combined with other drugs, as well as a Phase III clinical trial of the Astra Zeneca ChAdOX-1 SARS-CoV-2 vaccine. Rochester engineers and medical scientists are collaborating closely with clinicians to develop tests to detect coronavirus. Projects include (1) research on a finger-stick test to detect and study immunity to COVID-19; (2) the creation of tiny sensor chips that use coronavirus proteins to "very quickly" detect the presence of antibodies that help humans fight against the virus; and (3) testing samples of sputum, nasal mucus, or blood using ultrathin silicon nanomembranes to "instantly" determine if an individual has been infected. The Lung Development Molecular Atlas Program (LungMAP) and the Human BioMolecular Atlas Program (HuBMAP) collaboratives received funding from the NIH to examine human lung tissue in order to determine why children seemingly contract COVID-19 at a lower rate and remain more asymptomatic than the older population. Gloria Pryhuber, professor of Neonatology, will lead URMC's involvement in this multi-institutional project. The New York State Emerging Infections Program (EIP) is part of the federal Centers for Disease Control & Prevention's national effort to provide population-based communicable disease data to identify disease patterns, to evaluate vaccine programs, and to identify at-risk populations. The URMC EIP will be performing laboratory and population-based surveillance for COVID-19 as a part of multi-site national study. The group will collect a variety of demographic and clinical data that will be reported to the Centers for Disease Control & Prevention and the Monroe County Department of Public Health.

Please describe your research involving antibodies, memory B-Cells and the S-Subunit?

Dr. Mark Sangster in the Topham Lab has been studying acute and memory B cell (MBC) responses to COVID-19. We found evidence of pre-existing cross-reactive MBC specific for the S2 subunit of the spike glycoprotein and seasonal beta coronaviruses. This cross-reactive MBC responds more rapidly to infection and may affect responses to other SARS-CoV-2 proteins. Antibodies to the S2 subunit can be neutralizing. We are now trying to understand whether this immune memory is correlated with disease outcomes. We are also beginning studies of T cell responses to SARS-CoV-2 in acute and convalescent subjects.

Professional Summary

David Topham joined the faculty at the University of Rochester Medical Center in 1999 and was appointed in 2009 as Vice Provost and Executive Director of the Health Science Center for Computational Innovation (HSCCI), a partnership between New York State, the University and IBM. As Executive Director of the HSCCI, Dr. Topham's responsibility is to support collaboration in biomedical research using High Performance Computational Resources. He will bring together academic biomedical and health-related Research Investigators, High Performance Computational Biologists, and HP Research Computing resources. Dr. Topham provides strategic direction to the HSCCI and facilitates the development of research projects between UR scientists and its corporate partners, as well as support from state and federal agencies.

Dr. Topham is a Professor of Microbiology and Immunology, a member of the David H. Smith Center for Vaccine Biology and Immunology, and directs the New York Influenza Center of Excellence--one of the five national Centers of Excellence in Influenza Research and Surveillance supported by the NIH.

Dr. Topham was recently appointed as the Founding Director of the UR Translational Immunology and Infectious Diseases Institute whose mission is to foster collaborative team based approaches to translational research on infectious diseases and immunology.

About Topham Lab

Viruses that infect the respiratory tract are responsible for extensive morbidity and mortality in human population worldwide. Influenza virus is a particular concern because of its ability to periodically cause deadly pandemics, most recently in 2009 after the spread of a swine-origin H1N1 virus to humans. Novel avian influenza viruses such as H5N1 and H7N9 continue to cause sporadic cases of severe disease in humans and are an ongoing pandemic threat. An understanding of how the immune system controls influenza and other respiratory viruses and provides long-term protection is critical for the rational development of effective vaccination and treatment strategies.

Studies in our lab are primarily aimed at understanding the multiple roles of virus-specific B and T cells in determining the outcome of viral infection of the respiratory tract. In particular, we are interested in the character, longevity, and protective capacity of B and T cell memory induced by infection and vaccination. A large component of work in the lab focuses on the response of the human immune system to infection and vaccination; other work uses a variety of animal model systems to investigate basic immunological mechanisms. A recent initiative in the lab is the identification of viral genes and host responses that influence the severity of respiratory virus infections. This work will identify strategies for engineering new antivirals and improving vaccines.

Many projects involve strong collaborative interactions within centers at the University of Rochester that focus on immunity to respiratory pathogens. These centers include the Respiratory Pathogens Research Center (RPRC), the New York Influenza Center of Excellence (NYICE), and the University of Rochester Genomics Research Center (URGRC).

This year's class of Optical Society (OSA) Fellows includes Jake Bromage, a senior scientist at the Laboratory for Laser Energetics; Michael Campbell, director of the Laboratory for Laser Energetics; John Marciante, an associate professor of optics; and Benjamin Miller, Dean's Professor of Dermatology and a professor of biomedical engineering, optics, and biochemistry and biophysics. Fellows are selected for a range of achievements in the field of optics and photonics.

Congratulations Ben!

Seasonal colds are by all accounts no fun, but new research suggests the colds you've had in the past may provide some protection from COVID-19. The study, authored by infectious disease experts at the University of Rochester Medical Center, also suggests that immunity to COVID-19 is likely to last a long time -- maybe even a lifetime.

The study, published in mBio, is the first to show that the COVID-19-causing virus, SARS-CoV-2, induces memory B cells, long-lived immune cells that detect pathogens, create antibodies to destroy them and remember them for the future. The next time that pathogen tries to enter the body, those memory B cells can hop into action even faster to clear the infection before it starts.

Because memory B cells can survive for decades, they could protect COVID-19 survivors from subsequent infections for a long time, but further research will have to bear that out.

The study is also the first to report cross-reactivity of memory B cells -- meaning B cells that once attacked cold-causing coronaviruses appeared to also recognize SARS-CoV-2. Study authors believe this could mean that anyone who has been infected by a common coronavirus -- which is nearly everyone -- may have some degree of pre-existing immunity to COVID-19.

"When we looked at blood samples from people who were recovering from COVID-19, it looked like many of them had a pre-existing pool of memory B cells that could recognize SARS-CoV-2 and rapidly produce antibodies that could attack it," said lead study author Mark Sangster, Ph.D., a research professor of Microbiology and Immunology at URMC.

Sangster's findings are based on a comparison of blood samples from 26 people who were recovering from mild to moderate COVID-19 and 21 healthy donors whose samples were collected six to 10 years ago -- long before they could have been exposed to COVID-19. From those samples, study authors measured levels of memory B cells and antibodies that target specific parts of the Spike protein, which exists in all coronaviruses and is crucial for helping the viruses infect cells.

Whether flu or coronavirus, it can take several days for the body to ramp up an effective response to a viral infection. New research appearing in the journal Nature Immunology describes how different cells in the immune system work together, communicate, and -- in the case of cells called neutrophils -- bring about their own death to help fight off infections. The findings could have important implications for the development of vaccines and anti-viral therapies.

"The immune system consists of several different types of cells, all acting in coordination," said Minsoo Kim, Ph.D., a professor of Microbiology and Immunology at the University of Rochester Medical Center (URMC) and senior author of the study. "These findings show that cells called neutrophils play an important altruistic role that benefits other immune cells by providing key resources for their survival and, in the process, enhancing the body's immune response against a virus."

Neutrophils are a key component of the innate immune system, the part of the body's defenses that is always switched on and alert for bacterial and viral invaders. The vast majority of white cells circulating in blood are neutrophils and, as a result, these cells are the first on the scene to respond to an infection.

However, neutrophils are not fully equipped to eliminate a viral threat by themselves. Instead, when the respiratory tract is infected with a virus like influenza or COVID-19, a large number of neutrophils rush to the infection site and release chemical signals. This triggers the production of specialized T cells, which are part of the body's adaptive immune system, which is activated to produce a more direct response to specific infections. Once mobilized in sufficient quantities, a process that typically takes several days, these T cells target and ultimately destroy the infected cells.

The new study, which was conducted in mice infected with the flu virus, shows that in addition to jump-starting the adaptive immune response, neutrophils have one more important mission that requires that they sacrifice themselves. As T cells arrive at the infection site, the neutrophils initiate a process called apoptosis, or controlled death, which releases large quantities of a molecule called epidermal growth factor (EGF). EGF provides T cells with the extra boost in energy necessary to finish the job.

"This study represents an important paradigm shift and shows that the adaptive immune system doesn't generate a successful response without instruction and help from the innate immune system," said Kim. "The findings reveal, for the first time, how different immune cells work together, and even sacrifice themselves, to accomplish the same goal of protecting the host from the viral infection."

Clinical Trials on a Chip researchers plan to build and test common and rare disease models to help improve the clinical trial process.

Approximately 85% of late-stage clinical trials of candidate drugs fail because of drug safety problems or ineffectiveness, despite promising preclinical test results. To help improve the design and implementation of clinical trials, the National Institutes of Health has awarded 10 grants to support researchers' efforts in using tiny, bioengineered models of human tissues and organ systems to study diseases and test drugs. One major goal of the funded projects is to develop ways to better predict which patients are most likely to benefit from an investigational therapy prior to initiating clinical trials.

The awards total more than $6.9 million in the first year, and approximately $35.5 million over five years, pending available funds. They are administered through a new program, Clinical Trials on a Chip, which is led by NIH's National Center for Advancing Translational Sciences (NCATS) in conjunction with several other NIH Institutes and Centers, including the National Cancer Institute, the National Institute of Child Health and Human Development, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Tissue chips, or organs-on-chips, are 3-D platforms engineered to support living human tissues and cells and mimic complex biological functions of organs and systems. Tissue chips are currently being developed for drug safety and toxicity testing and disease modeling research, including on the International Space Station. Clinical Trials on a Chip is one of several initiatives that are a part of the NCATS-led Tissue Chip for Drug Screening program, which was started in 2012 to address the major gaps in the drug development process.

The UR Center for RNA Biology offered an exercise during the time when COVID-19 became a sufficient threat to largely shut-down our research enterprise. We're pleased to announce the winners of the UR's Center for RNA Biology Essay Contest on "The role of RNA research in community health". These awards are sponsored by a grant from the RNA Society & Lexogen to the UR Center for RNA Biology, and funds from UR RNA Structure & Function Cluster.

Our Gold prize (~$1,000 value) award goes to Sydney Simpson, an Immunology, Microbiology & Virology graduate student in Steve Dewhurst's lab in the Department of Microbiology & Immunology, for her essay: "Nucleoside Analog Inhibitors: Timeless & Timely Beacons of Hope".

The Silver Prize (~$250 value) award goes to Omar Hedaya, a Biochemistry & Molecular Biology graduate student in Peng Yao's lab in the Department of Medicine/Department of Biochemistry & Biophysics, for his essay: "Know the Fundamentals when Seeking the Future".

Omar Hedaya

Sydney Simpson

Both awardees have become members of the RNA Society and will use their winnings toward technology needs for the upcoming semester.

The RNA Society now features our contest results, including the winning essays, in its latest RNA Salon update: https://www.rnasociety.org/featured-salons, see bullet #3.

We would like to acknowledge Honorable Mentions for the following applicants:

• Sai Shashank Chavali -- Graduate student; Biophysics, Structural & Computational Biology; Wedekind Lab
• Lily Cisco -- Graduate student; Cellular and Molecular Pharmacology & Physiology; Lueck Lab
• Gabrielle Kosoy -- Graduate student; Biophysics, Structural & Computational Biology; Miller Lab
• Ashwin Kumar -- Graduate student; Biophysics, Structural & Computational Biology; Topham Lab
• Li Xie -- Graduate student; Genetics, Development & Stem Cells; Pröschel Lab

We thank all who participated -- and our judges, too!

Research scientists aren't born, they're made -- and it doesn't happen overnight. A critical factor in their early development: seed funds to launch their own research projects.

Federal and University of Rochester-sourced funds help young researchers at CMSR build skills in scientific investigation, writing research papers and grant proposals, and presenting their work. A relatively modest investment in promising researchers yields big returns for them.

A core belief of the CMSR is that outstanding New/Early Stage Investigators (N/ESI, defined by NIH as faculty who have not received a large independent research grant) who gain access to pilot research funding, and state-of-the-art research equipment, will produce the preliminary data necessary to support their NIH R01 and K-award applications, and establish themselves as independent investigators and national leaders in their respective field. Evidence that the CMSR is excelling with this primary mission comes from the remarkable 42-fold return on investment (ROI) on its NIH P30 Core Center Pilot Program. The CMSR extended a total of $500K in pilots from 2014-2018 ($100K per year, approximately $22.7K per award to 24 awardees, including 2 applicants that only received Research Core support, but no budget).

These pilots catalyzed $21,169,818 in extramural funding from NIH and other agencies (direct cost only) to date. Beyond the financial ROI, the pilots enabled 62 publications and resulted in 17 faculty promotions. To add to its P30 Pilot Program, the CMSR plans to award $30K from a new Discovery Fund (awards up to $5,000 to be used in the CMSR's Research Cores), which will be expeditiously awarded by the CMSR's Mentoring Core without a formal grant application or review process.

"At a time when federal funding for investigations is at a premium -- and when many young researchers choose industry over academic research -- every dollar matters so much," said Edward Schwarz, Ph.D., Richard and Margaret Burton Distinguished Professor of Orthopaedics and Director of CMSR. "P30 funding enables our researchers to move from collaborating on our PIs' research projects, to working independently and developing autonomy, discipline, experience and professional networks that will serve them over the course of their careers, and help us develop research scientists for the future."

Abstract

Efficacious HIV-1 vaccination requires elicitation of long-lived antibody responses. However, our understanding of how different vaccine types elicit durable antibody responses is lacking. To assess the impact of vaccine type on antibody responses, we measured IgG isotypes against four consensus HIV antigens from 2 weeks to 10 years post HIV-1 vaccination and used mixed effects models to estimate half-life of responses in four human clinical trials. Compared to protein-boosted regimens, half-lives of gp120-specific antibodies were longer but peak magnitudes were lower in Modified Vaccinia Ankara (MVA)-boosted regimens. Furthermore, gp120-specific B cell transcriptomics from MVA-boosted and protein-boosted vaccines revealed a distinct signature at a peak (2 weeks after last vaccination) including CD19, CD40, and FCRL2-5 activation along with increased B cell receptor signaling. Additional analysis revealed contributions of RIG-I-like receptor pathway and genes such as SMAD5 and IL-32 to antibody durability. Thus, this study provides novel insights into vaccine induced antibody durability and B-cell receptor signaling.

With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine.

But that speed—and some widely touted breakthroughs—belie the enormous complexity and potential risks involved. Researchers have an incomplete understanding of the coronavirus and are using technology that's largely unproven.

Among many worries: A handful of studies on COVID-19 survivors suggest that antibodies—key immune system proteins that fight infection—begin to disappear within months. That's led scientists to worry that the protection provided by vaccines could fade quickly as well. Some even question whether vaccines will really end the pandemic. If vaccines produce limited protection against infection, experts note, people will need to continue wearing masks and social distancing even after vaccines roll out.

People with severe symptoms from COVID-19 tend to have higher antibody levels than those with milder cases.

Some people fail to generate antibodies because they have compromised immune systems, said Mark Sangster, a research professor at the University of Rochester Medical Center.

Even when people do generate antibodies against the novel coronavirus, studies suggest the antibodies may not last long.

When the first COVID-19 cases hit the University of Rochester Medical Center's ICU back in March of 2020, there were no proven treatments available, but experimental therapies were cropping up around the world. Quickly, a team of URMC clinicians and researchers mobilized to bring the most promising clinical trials - that address the broadest swath of patients' needs - to URMC. Since then, URMC has joined three clinical trials that provide extra treatment options for some of the sickest COVID-19 patients.

COVID-19 causes a wide range of outcomes: some infected people never show a single symptom, while many battle the disease for weeks in the ICU. The difference between those outcomes seems to lie in a careful balance of the immune response. In the beginning of the disease, the immune system helps fight off the virus. But for those who land in the hospital, this early, helpful immune response gives way to uncontrolled over-activation of the immune system, causing system-wide inflammation and severe complications.

The three COVID-19 inpatient clinical trials currently running at URMC attack the disease at both ends of this balance.

"Our goal has always been to promote effective therapies through clinical trials," said Martin Zand, M.D., Ph.D., senior associate dean for Clinical Research and co-director of the Clinical & Translational Science Institute. "Our team is working hard to make sure that the trials we bring to URMC have the greatest chance of benefiting our own patients, and significantly advancing the science of COVID-19 to benefit patients around the world."

Quieting Inflammation at All Ages

While researchers have high hopes that baricitinib can quell the over-exuberant immune activity of COVID-19, that trial is only open to patients who are 18 years old and up. Another trial, sponsored by Incyte Corp, is testing a very similar drug, called ruxolitinib, in patients as young as 12 who have very severe COVID-19 disease and need to be on a ventilator.

When the immune system runs amok in the late stages of COVID-19, the lining of the lungs can become leaky, allowing fluid to build up in the lungs' air sacs. This phenomenon, called acute respiratory distress syndrome, starves the body of oxygen and mechanical ventilation can even fail to rescue these patients.

The URMC team, led by Christopher Palma, M.D. and Steve Georas, M.D., expects to enroll up to 20 severely ill COVID-19 patients in the trial to see if ruxolitinib can keep them alive and get them off ventilators and out of the ICU sooner.

Action for AT Foundation awards a grant for an exciting new collaboration between the O'Reilly and Mayer-Proschel labs that will investigate how recurrent respiratory viral infections causes ataxia-telangiectasia mutated neurologic disease.

While other cancer researchers had to temporarily close their labs in March due to the COVID-19 pandemic, Isaac Harris, Ph.D., and Josh Munger, Ph.D., shifted their focus to the contagion that has reshaped the world.

Using their specialized knowledge of viruses and genomics technology at the Wilmot Cancer Institute, the duo is searching for new and existing, U.S Food and Drug Administration-approved medications that could block the coronavirus.

They've tested 624 drugs on thousands of human lung cells infected with a strain of the coronavirus to see if the drugs have any impact. So far, they've discovered 15 potential compounds that appear to have anti-viral activity. Their criteria for a "hit" is for the drug to block 50 percent of virus-induced cell death. The team is validating the 15 drugs and trying to understand the mechanisms behind their potential anti-viral activity, Harris said.

This type of research is known as high-throughput drug screening -- a process that plays a big role in drug discovery in modern medicine. But instead of finding a new drug, here, investigators are looking to repurpose existing, available drugs for treatment of the coronavirus. This involves using automated, robotic equipment to match drug candidates with cellular events that occur during disease transformation. This form of drug-screening is often less expensive and faster than developing treatments from scratch.

Matthew L. Rook, M.S. (MacLean Lab) has been awarded a Joan Wright Goodman Dissertation Fellowship for 2020-2021! This fellowship was endowed by Joan Wright Goodman, PhD class of 1952, to support doctoral students across disciplines in the sciences. It is one of the University's most competitive dissertation fellowships and is given to students who display exceptional ability and promise. It is a testimony to the University's commitment to supporting your scholarship.

The award is $20,000, and must be used over at least 9 months between July 1, 2020 and June 30, 2021. Congrats Matthew!

Please congratulate Tom Mariani, who is this year's recipient of the Andy Tager Award for Excellence in Mentoring!

Tom's dedication to scientific inquiry into lung biology, and his enduring effort to lift all boats with a rising tide made him the perfect fit for this award!

"Assembly on Respiratory Cell & Molecular Biology Andy Tager Award for Excellence in Mentoring"

Dr. Andy Tager was a remarkable physician scientist who combined his talent as an astute and caring physician, with that of a creative and insightful scientist, and with a lifelong dedication to helping others. Dr. Tager received multiple national awards for his discovery of bioactive lipids as potential targets of therapy in interstitial pulmonary fibrosis and distinguishing himself as one of the few to fulfill the dream of taking his work from bench to bedside. He was a selfless mentor to trainees and colleagues at his home institution, caring for the careers of those he was mentoring at least as much as his own. Less obvious to others, through his many leadership roles at ATS, Dr. Tager helped promote the professional careers ATS of members, particularly the RCMB Assembly, from all over the world. The Andy Tager Award for Excellence in Mentoring is our tribute to the brilliant, caring man, whose selfless dedication touched so many hearts, in more ways than one."

Congratulations to Viktoriya Anokhina who was elected as a co-chair of the Gordon Research Seminar Nucleosides, Nucleotides and Oligonucleotides, to be held in 2021. The Gordon Research Seminar is a 2-day meeting that precedes a Gordon Research Conference. These seminars are organized by early-career scientists for trainees of all levels and junior scientists. Some of Viktoriya's responsibilities as a co-chair will include Keynote speaker selection and invitation, career panel participants invitations, fundraising, selection of speakers from submitted abstracts, and other organizational activities. To attend the 2019 meeting, Viktoriya was supported by the Sayeeda Zain and Graduate Women in Sciences travel awards.

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.

Congratulations to Lung Biology Program members Drs. Georas, Mariani and Dean who all received the following grants:

P.I.: Steve Georas, MD
NIH/NIAA

Award Number : 1 R01 AI144241-01A1

Title of Project: Novel role of protein kinase D in airway inflammation and antiviral immunity

Project Period: 3/13/20 -- 2/28/25?

P.I.: Tom Mariani, PhD

Agency: CTSI Pilot Project Program/NIH

Award Period: 7/1/20 -- 1/31/21

Total Award (TPC): $50,000

Title: Airway Biomarkers for Prediction of ARI Etiology (Internal Grant)

The overall goal of this project is to show that airway sampling will provide optimal diagnostic biomarkers for determining bacterial involvement in ARI.

P.I.: David Dean ,PhD

Agency: NIH/NHLBI

Award Period: 4/5/20- 3/31/24

Total Award (TPC): $2,298,764

Title: A multimodal delivery and treatment approach for Acute Lung Injury (R01)

This projects investigates how gene transfer of the b1 subunit of the Na,K-ATPase to the lung increases not only alveolar fluid clearance, but also improves alveolar-capillary barrier function by up regulating abundance and activity of tight and adherent junction complexes.

P.I.: David Dean, PhD

Agency: NIH/NIDDK

Award Period: 4/15/20 -- 3/31/23

Total Award (TPC): $1,588,524

Title: Gene therapy for GERD-associated esophageal epithelial barrier dysfunction (R01)

Gen transfer of the b1 subunit of the Na,K-ATPase can upregulate tight and adherence junctions abundance and activity in the lung. Since a hallmark of gastroeosphageal reflux disease (GERD) is reduced barrier function in the distal esophagus (which may play a role in ultimate transition to esophageal adenocarcinoma), this project investigates whether gene delivery of the b1 subunit of the Na,K-ATPase can restore esophageal barrier integrity and therefore reduce GERD.

P.I.: David Dean, PhD

Agency: Cystic Fibrosis Foundation

Award Period: 2-1-20 -- 1-31-23

Total Award (TPC): $840,000

Title: : Electroporation-mediated gene delivery to the airways to treat Cystic Fibrosis (grant)

This project investigates whether electroporation-mediated gene transfer can be used to effectively sustain long-term expression of CFTR in animal models. If successful, the project may lead to the development of new therapies designed to treat people with cystic fibrosis.

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.

University scientists are adapting existing research to develop tests to detect and improve our understanding of COVID-19. Examples include projects led by Martin Zand, senior associate dean for clinical research at the Medical Center; Benjamin Miller, a professor of dermatology and biomedical engineering; and James McGrath, a professor of biomedical engineering.

Zand is working on the finger-stick test, which uses patented technology that detects immunity to more than 50 strains of flu. The test comes in an easy-to-mail kit similar to those that test blood sugar for diabetes. "We're hoping this could make COVID-19 vaccine trials faster and more convenient for those who volunteer for them," says Zand.

Miller's lab hopes to find the virus with optics at the nanoscale. The lab is developing tiny sensor chips that use coronavirus proteins to "very quickly" detect the presences of immunoglobulin G and M antibodies that humans develop within two days of exposure to the virus. "The problem right now is actually getting patient samples," says Miller. "Meanwhile we are optimizing our assays with 'normal' serum samples doped with coronavirus antibodies—basically making artificial patient samples."

McGrath is using ultrathin membranes—less than 200 nanometers thick—to determine whether individuals have been infected with COVID-19. He can apply the membranes as a sensor and as a platform for discovering pathogenic mechanisms. McGrath is eyeing an inexpensive device similar to a pregnancy test that could be used in low-resource communities around the world.

"It will likely take more than a year to develop a vaccine, so COVID-19 is going to be with us for some time," says McGrath. "If we move quickly but deliberately, I think the device could be ready in time to help with the current pandemic."

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.

Two faculty members at the University of Rochester—Benjamin Miller and Marvin Doyley—have been inducted as fellows of the American Institute for Medical and Biological Engineering (AIMBE).

The institute's College of Fellows is composed of the top 2 percent of medical and biological engineers, who are employed in academia, industry, clinical practice, and government.

As a result of health concerns, AIMBE's annual meeting and induction ceremony scheduled for March 29-30 was canceled, but Miller and Doyley were remotely inducted as part of a total of 156 fellows who make up the Class of 2020.

Marvin Doyley, professor of electrical and computer engineering with joint appointments in biomedical engineering, and imaging sciences, was selected for "outstanding contributions in developing algorithms for elastography and the application of elastography to vascular mechanics and disease."

Doyley joined the University of Rochester in 2008. His Parametric Imaging Research Laboratory develops novel imaging methods for detecting disease more quickly and for determining how well patients are responding to therapy. Doyley's primary research interests include cardiovascular imaging, breast cancer imaging, ultrasound beamforming, contrast-enhanced ultrasound imaging, ultrasound elastography, magnetic resonance elastography, and pancreatic cancer imaging.

"It is an honor to be named an AIMBE fellow, which is due to the hard work of my research groups, past and present," Doyley says.

Doyley was also one of 20 faculty members nationwide recently selected for the first cohort of the IAspire Leadership Academy, a program aimed at helping STEM faculty from underrepresented backgrounds ascend to leadership roles at colleges and universities.

Benjamin Miller, the Dean's Professor of Dermatology with joint appointments in biomedical engineering, biochemistry and biophysics, and optics, was selected for "the development and application of versatile optical biosensor platforms, including Arrayed Imaging Reflectometry and integrated photonic sensors."

Miller, who was also recently named a fellow of the American Association for the Advancement of Science (AAAS), joined the Rochester faculty in 1996. He is focused on two areas of research: how molecules recognize RNA sequences; and how the optical properties of nanomaterials might aid in the development of new biosensors for biological investigations and clinical screenings. The Miller lab hopes to pave the way toward compact, inexpensive biosensors that could replace current floor-standing clinical diagnostic systems with a cell phone--sized device.

"Being named an AIMBE Fellow recognizes the hard work my students and other group members have done over the years," Miller says, "and I hope it will spur us to continue to make new diagnostic tools for improving human health."

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.