Cook County Health is participating in a Phase III, randomized, double-blinded, placebo-controlled trial for a COVID-19 vaccine known as AZD1222. Cook County Health is one of three centers in the Chicago area participating in the study.
Oxford University’s Jenner Institute and Oxford Vaccine Group developed AZD1222. The candidate vaccine was licensed to AstraZeneca for further development. AstraZeneca is leading the Phase III trial. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, 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, are providing funding support for the trial.
Cook County Health is part of the NIAID-supported COVID-19 Prevention Network (CoVPN), which is composed of existing NIAID-supported clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
Unlike the Phase I and II trials that primarily looked at the safety data of the vaccine and documented the antibody response on test subjects, the Phase III trial will evaluate if the vaccine will actually prevent symptomatic COVID-19.
“The effects of COVID-19 have been devastating and have had a significant impact on our way of life. It is critical to identify new strategies to combat this pandemic,” said Dr. Temitope Oyedele, an infectious disease expert at Cook County Health and principal site investigator of the vaccine trial. “This trial is an important step in determining whether an effective vaccine can be developed to halt the COVID-19 pandemic.”
Study participants for the clinical trial must be 18 years or older and be willing and able to provide written, informed consent prior to the start of study procedures. Study investigators are looking for candidates who are considered at an increased risk of contracting COVID-19 and have never tested positive for the virus.
The vaccine is being compared to a placebo in this double-blinded trial; both the investigators and participants do not know who is receiving the investigational vaccine. The study drug and the placebo will be administered via injection in two doses. Two-thirds of the participants will receive the study drug, while the other third will receive an injectable placebo.
Study participants will be followed for a two-year period. After enrollment and initial administration of either the vaccine or placebo, participants will then receive a second dose a month later. During the two-year period, participants will be required to complete five in-person visits and two telehealth visits. If they develop COVID-19 symptoms over this time period, participants will have a few additional visits to be properly evaluated and monitored.
Elizabeth Pedersen, Communications Manager