The University of Rochester Medical Center (URMC) is joining a phase 3 clinical trial for a potential coronavirus vaccine being developed by AstraZeneca and the University of Oxford known as AZD1222.
This is the second phase 3 coronavirus vaccine study to be conducted in Rochester. On July 27, four volunteers in Rochester were the first in the nation to receive an experimental vaccine being developed by Pfizer and BioNTech. Rochester was one of only four sites in the nation that also participated in early-stage studies of the Pfizer/BioNTech vaccine. Phase 3 represents the final stage of human testing prior to regulatory approval, production, and mass distribution.
The Rochester arm of the AstraZeneca study is being led by Ann Falsey, M.D., Angela Branche, M.D., Mike Keefer, M.D., and Catherine Bunce, B.S., M.S. Falsey and Branche oversee the URMC Vaccine and Treatment Evaluation Unit and Keefer and Bunce lead the URMC HIV Vaccine Trials Unit. Both programs are part of the national COVID-19 Prevention Network (CoVPN), which was formed by the National Institute of Allergy and Infectious Diseases (NIAID) to help lead the scientific response to the pandemic. NIAID is headed by Anthony Fauci, M.D.
The vaccine being developed by the British and Swedish company AstraZeneca and the University of Oxford uses a harmless adenovirus that contains the genetic material of the COVID-19 spike protein. The vaccine stimulates production of the surface spike protein, which primes the immune system to recognize the virus if infected.
Phase 1/2 studies conducted in the U.K. – the results of which were reported on July 20 in the journal Lancet – found that the vaccine was not only safe but generated an immune response to the virus. Whether or not the vaccine provides protection from coronavirus infection across a wide range of age groups and medical conditions are questions that the phase 3 study will now seek to answer. In addition to the U.S., phase 3 studies of the vaccine are also underway in the U.K., Brazil, and South Africa.
The AstraZeneca trial is funded by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The trial is being implemented as part of the Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19.
The randomized placebo-controlled clinical trial will recruit 30,000 people across 81 sites in the U.S. including 1,000 volunteers in Rochester. Researchers are focusing on individuals in the Rochester area ages 18 to 85 who are at greater risk for coronavirus infection, such as health care workers, first responders, teachers, and people who work in restaurants or retail. Because COVID-19 has had a disproportionate impact on people of color, researchers are working with community partners to invite Black and Latinx individuals to participate in vaccine trials.