The University of Vermont Medical Center and Vaccine Testing Center at the University of Vermont’s Larner College of Medicine have been selected to take part in a Phase 3 trial for a COVID-19 vaccine developed by Oxford University and manufactured by AstraZeneca.
The AZD1222 COVID-19 VACCINE Study is researching an investigational vaccine for the prevention of COVID-19, the disease caused by the novel coronavirus (SARS-CoV-2). The study will track the safety and effectiveness of the investigational vaccine. Approximately 30,000 participants from the United States will take part in this study, including at least 250 people locally.
“This is an exciting opportunity for our area to help develop a safe and effective vaccine for COVID-19 and control the ongoing pandemic,” said Beth Kirkpatrick, M.D., a specialist in Infectious Diseases at UVM Medical Center and director of the Larner College of Medicine’s Vaccine Testing Center.
Dr. Kristen Pierce, also a specialist in Infectious Diseases at the UVM Medical Center, who leads the study and the Vaccine Testing Center with Dr. Kirkpatrick, adds, “We have significant experience testing vaccines at the University of Vermont and are proud to take part in this national effort. Volunteers will receive high-quality care throughout their participation and will be helping the global community move beyond the threat of COVID-19 by participating.”
“The UVM Health Network is proud to highlight the value of an academic medical center in our region that can help contribute to the global effort to control the COVID-19 pandemic,” said John R. Brumsted, M.D., President and CEO of the UVM Health Network. “It’s an honor to be part of a solution that will improve people’s lives here at home and around the world.”
“Our team at the UVM Medical Center has worked hard to get us to this point, and I am confident that by working with members of our community on this trial, we will make a real contribution to the fight against COVID-19,” said Stephen Leffler, M.D., President and COO of the UVM Medical Center.
“Most people don’t know that, thanks to ongoing research by Drs. Kirkpatrick and Pierce and the Vaccine Testing Center team, our college was already poised to contribute to the fight against this novel coronavirus,” said Richard L. Page, M.D., Dean of UVM’s Larner College of Medicine. “This vaccine trial will combine our research excellence with the outstanding clinical care provided by our partners at UVM Health Network and the UVM Medical Center, to bring us closer to eliminating this pandemic.”
"We’re happy the AstraZeneca trial is moving forward, and delighted our academic medical center can contribute to our knowledge, and that Vermonters – especially those who may benefit most from the vaccine – will have the chance to volunteer for the study,” said Department of Health Commissioner Mark Levine, M.D. "The vaccine being tested is receiving an appropriately vigorous review from the scientific community -- a critical component for any study protocol or drug."
The trial will require at least 250 local volunteers from Vermont, Northern New York and New Hampshire. Those who may be eligible to take part in the study include people who:
- Are 18 years of age or older; with a special emphasis on individuals over 65 years of age;
- Are in good or stable health (you may have an underlying medical condition and still take part, if your condition is stable);
- Have an increased risk of getting COVID-19 clinical (symptomatic) illness; and
- Do not have a previously confirmed diagnosis of COVID-19.
Participants will be randomly assigned to receive either two injections of the investigational vaccine or a placebo. A placebo looks like the investigational vaccine but contains no active vaccine. Participants will have twice as much chance of receiving the investigational vaccine as of receiving a placebo. If you are approved for the study and take part, you will be in the study for approximately two years and it will require several visits to our study center. Additional visits will be required if you develop symptoms suggesting COVID-19 during the study. Your health will be monitored carefully by a team of doctors and nurses throughout the study. The study injections, health assessments, and medical tests related to the study will be provided at no cost to you.
Before deciding whether to take part, volunteers will be provided with all the information needed to make an informed decision. Volunteers will have a chance to ask questions. Additionally, volunteers will be given time to decide if they want to take part in the study.
Results from initial Phase I/II trials of the vaccine, led by Oxford University, showed it "was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants," according to AstraZenaca.
The study will last approximately two years and includes three parts: screening, study treatment (vaccination or placebo), and follow-up. The screening portion and first vaccine will usually occur on the first visit. During this time volunteers will visit the study center to learn about the study and decide if they wish to participate. If eligible and enrolled, they will receive the first study treatment. The second study treatment will take place four weeks later. Participants will be in frequent contact with the study staff to review any potential symptoms. The follow-up phase will last up to two years, and participants will visit the study center several times for study assessments. Participants will be compensated for their time.
Anyone interested in participating in the trial can find more information at UVMHealth.org/COVIDStudy, or by calling 802-847-7339.