Oregon Health & Science University is seeking Portland-area residents to participate in a research study evaluating a potential COVID-19 vaccine.
OHSU is the only Oregon institution involved in a Phase 3 clinical trial evaluating the novel coronavirus vaccine candidate developed by Oxford University and the pharmaceutical company AstraZeneca. The trial seeks to enroll a total of 30,000 participants nationwide to evaluate the safety and effectiveness of the investigational vaccine known as AZD1222. The experimental vaccine is designed to be given in two injections that are administered about four weeks apart.
Portland-area adults interested in enrolling in the trial should go to www.c19vaccinestudy.com or call 888-VAC-STDY (888-822-7839) for more information. Trial participants must be 18 or older, not be pregnant, have either stable medical conditions or no medical issues, have not been previously diagnosed with COVID-19, and should live within approximately 1.5 hours of OHSU’s Marquam Hill/South Waterfront campus in Portland, among other criteria. Participants will be monitored for two years.
“Oregon Health & Science University is proud to contribute to the world’s most pressing challenge right now: identifying a safe and effective COVID-19 vaccine for everyone,” said OHSU President Danny Jacobs, M.D., M.P.H., FACS. “We’re asking Portland-area residents to volunteer for this trial and help bring all of us closer to stopping this devastating pandemic.”
OHSU wants COVID-19 vaccines to work well for the broadest group of people possible, and particularly for communities that have been hardest hit by the coronavirus pandemic. The study strives to enroll a diverse group of trial participants, and prioritizes the enrollment of individuals who are older than 55 and Black, Indigenous and People of Color.
To help achieve this, Marcel Curlin, M.D., OHSU’s lead investigator on the study and an associate professor of infectious disease in the School of Medicine, has been holding a series of virtual gatherings with multiple community groups to describe the trial and discuss how best to encourage community participation.
Interim results from the experimental vaccine’s Phase 1/2 trial in the U.K. showed it generated a robust immune response and led to mild or moderate adverse reactions such as headaches, fatigue and chills, according to a scientific paper published in The Lancet in July.
As part of the standard review process for trial safety events, AstraZeneca temporarily and voluntarily paused its vaccine trial Sept. 6 when a trial participant experienced unexplained neurological symptoms. The trial resumed in the U.S. on Oct. 23 after the FDA reviewed the study’s global safety data and determined it was safe for the trial to continue.
This is a randomized trial where two-thirds of participants will receive the experimental vaccine and one third will receive a placebo. It is also a double-blind study, meaning neither the participants nor the clinicians involved will know who receives the vaccine candidate or the placebo. Phase 3 trials provide expanded information about drug candidates, including evaluating their overall risks and benefits, and are often the last step before requesting FDA approval for a drug’s widespread use.
The trial is funded by AstraZeneca, the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
Dec. 1, 2020, UPDATE: This announcement was revised to clarify the trial's 30,000 enrollment target refers to the total number of the people AstraZeneca and Oxford University aim to enroll in the trial nationwide.
Feb. 1, 2021, UPDATE: Nationwide enrollment in the Phase 3 AstraZeneca and Oxford University-led COVID-19 vaccine trial has been completed. Between Nov. 30, 2020, and mid-January, 2021, OHSU enrolled 111 trial participants, the majority of whom are Black, Indigenous and People of Color.