Research News

Pulmonary arterial hypertension is a rare, life-threatening disorder characterized by high blood pressure in the arteries of the lungs. Current methods for diagnosing this condition can be cumbersome, expensive and not entirely reliable. Daniel Lachant, DO, Associate Director of the Pulmonary Hypertension Program at Mary Parkes Center for Asthma, Allergy and Pulmonary Care, has been awarded a grant (URMC KL2 Scholars Award) to study whether cardiac effort (the number of heart beats required for a person to walk a given distance) is a more sensitive and reliable measure to monitor patients. Dr. Lachant will also develop a remote, mask-free assessment of cardiac effort and heart rate expenditure that patients can perform in the comfort of their own homes.

The University of Rochester Medical Center is participating in a new clinical trial that will mix-and-match the initial regime of an approved vaccine with a booster dose from a different manufacturer. The research will help inform public health decisions around re-vaccination schedules and the deployment of boosters that target COVID variants. The study is being led by Ann Regina Falsey, MD, Angela Branche, MD, co-directors of the URMC Vaccine and Treatment Evaluation Unit (VTEU), and David M Dobrzynski, MD, an assistant professor of Medicine, Infectious Diseases.

Read more: New Study Mismatches Vaccine Doses to Boost Immunity to COVID and Variants

Our faculty will test the Pfizer/BioNTech SE vaccine on 200 to 300 children ages six months to 11 years. URMC previously announced its participation in pediatric trials for the Moderna vaccine (March 18). Jennifer Nayak, M.D., associate professor in the Department of Pediatrics and the Division of Infectious Diseases and Microbiology and Immunology, and Mary Caserta, M.D., professor in the Department of Pediatrics, Division of Infectious Diseases, will be monitoring progress of the study.

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The Medical Center is joining a national clinical trial to study the immune responses of women who get their COVID-19 vaccination during pregnancy or shortly after giving birth. Led locally by Angela Branche, MD, Co-director of the Vaccine Trials and Evaluation Unit, the study will determine the safety and efficacy of the vaccines during pregnancy, as well as investigate whether moms can pass COVID-19 protection onto their babies—either in the womb or via breast milk after they're born.

The Medical Center and Rochester Regional Health have joined national studies to test a vaccine for a new South African variant of the coronavirus. The new vaccine, produced by Pfizer and BioNTech, is a slight twist on the companies' existing COVID-19 vaccine. The studies are led by Edward Walsh, MD, Professor of Medicine, and Ann Falsey, MD, Professor of Medicine and Infectious Diseases and Codirector of the Medical Center's Vaccine and Treatment Evaluation Unit.

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The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) have begun a new clinical trial that will evaluate the safety and efficacy of a third dose of the Pfizer/BioNTech COVID-19 vaccine. The vaccine is currently approved for a two dose regimen. This study represents an important step in the development of long-term vaccination strategies, including the creation of booster doses that target coronavirus variants.

"While widespread vaccination is the key to moving past the current health crisis, COVID-19 has the potential to become a seasonal and mutating virus," said Ed Walsh, M.D., and infectious disease specialist at URMC. "This study will help us understand important questions about the safety and immunogenicity of multiple doses of an mRNA vaccine, information that could ultimately enable us to extend the protection of vaccines and develop tailor-made, variant-specific boosters."

URMC and RRH have been involved in the development of the Pfizer/BioNTech vaccine since the launch of phase 1 clinical trials in May 2020 when volunteers in Rochester were among the first in the nation to receive the then experimental vaccine. Rochester was also a site for the phase 2/3 clinical trials that ultimately led to the vaccine's emergency use authorization (EUA) by the U.S. Food and Drug Administration last December. Since then, tens of millions of people across the globe have received at least one dose of the Pfizer/BioNTech vaccine.

The new study will involve individuals who participated in the phase 1 trials last spring, all of whom were fully vaccinated more than 6 months ago. Over the next several weeks, researchers will dose 144 volunteers, including 35 in Rochester, with a booster dose of the EUA-approved Pfizer/BioNTech vaccine. Rochester is one of four sites in the U.S. involved in the study.

The local studies are led by Walsh and Ann Falsey, M.D.; both hold faculty appointments in the URMC Department of Medicine, Infectious Diseases and are members of the Infectious Disease Unit at RRH. 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.

While the duration of protection provided by the Pfizer/BioNTech vaccine is unknown, it is assumed that immunity wanes over time, a phenomenon common in vaccines for other infectious diseases. The trial will measure the boost to the immune system and evaluate in the lab whether antibodies and other immune cells generated after the third dose provide protection against coronavirus variants. The study will also seek to answer is how well a third dose of the vaccine is tolerated in healthy volunteers and researchers will closely monitor participants for side effects.

The findings of the study will also be important as vaccine developers have turned their focus to the development of vaccines that can be tailored to meet the threat of emerging strains of the virus. Pfizer and BioNTech announced today that the companies had begun discussions with regulatory agencies regarding an early stage clinical study to evaluate a modified version of approved vaccine.

"While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and efficacy against circulating strains," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed."

Angela Branche, M.D., Assistant Professor of Medicine (Infectious Diseases), knocked on doors in Rochester neighborhoods to talk about coronavirus and her research to ensure diverse participation in COVID-19 vaccine trials. Her efforts to combat mistrust in the Black community were highlighted in Reuters.