Help Us Find a Way to Prevent COVID-19
The AZD12222 COVID-19 Vaccine Study at the University of Vermont Medical Center is recruiting volunteers.
About This Study
What Is the AZD1222 COVID-19 Vaccine Study?
The AZD12222 COVID-19 Vaccine Study is researching a vaccine to prevent COVID-19. This study will be looking at how well a new vaccine works to prevent COVID-19 illness, and how well the vaccine is tolerated.
The study is now enrolling volunteers who are at risk of COVID-19 illness. Participants will be randomly assigned to receive two injections of either the vaccine or a placebo (that contains no vaccine), four weeks apart.
Approximately 30,000 volunteers across the United States are expected to take part in this study, and approximately four hundred will be enrolled at the UVM Medical Center.
What to Expect
You will be enrolled in the AZD12222 COVID-19 Vaccine Study for about two years. During this time, several tests and assessments will be performed to monitor your health. In brief, these will include:
- Review of your medical history and health, as well as your possible risk of exposure to COVID-19, to be sure you are eligible for the study
- Review of medications you are taking (and any changes during the study)
- Physical examinations
- Measurements of vital signs (including blood pressure, heart rate, breathing rate, oxygen saturation, temperature, etc.)
- Blood tests
- A COVID-19 test at the start of the study, and if you are ill during the study period
- Two injections of vaccine or placebo, one month apart
- Follow-up questions electronically or by phone
The AZD1222 COVID-19 Vaccine Study has two parts: screening / study treatment (vaccine or placebo) and follow-up.
1. Screening and Study Treatment
We encourage volunteers to complete screening and study treatment at the same visit. The screening component includes your full review of the study, risks and benefits, and requirements. You will spend one-on-one time with study staff to review all parts of the study before deciding whether or not to participate. You will read and sign the informed consent document, which outlines all parts of the study and what is known so far about this vaccine. If you agree to sign the informed consent document, the study team will continue with a review of your medical history, ask about medications taken and conduct a physical exam, draw blood, and collect a test for COVID.
If the study team finds that you qualify to participate and you are interested in proceeding, you will receive study treatment of either the vaccine or placebo (which looks like the vaccine but does not contain any actual vaccine). You have a two out of three chance of receiving the vaccine. A computer program will be used to determine if you get the vaccine or the placebo. The study team will contact you seven days later to check in. You will be able to reach the study staff 24/7, if needed.
One month later, you will return for your second study treatment; the same practices will be done.
Since the study has a short time to enroll volunteers, we encourage (and will help) volunteers review materials in advance, so that the screening and first study treatment can be done on the same day. If necessary, they can be done in two visits (within 14 days of one another).
The followup period will last about two years.
After you have received the two doses of the study treatment (either the vaccine or the placebo), you will have six additional scheduled visits to the study center. These visits will occur at approximately 2, 3, 6, 12 and 24 months after you first received study treatment. You will also receive regular phone calls, emails and / or text messages asking if you have any symptoms of COVID-19. If you develop symptoms of COVID-19, you may be asked to come to the study clinic for additional visits.
Who Can Take Part?
Full review of your eligibility will occur during the screening period.
You may be eligible to take part in the study if you:
- Are 18 years of age or older
- Are in stable health
- Have an increased risk of getting COVID-19 illness
- Do not have a previously confirmed diagnosis of COVID-19
You may need to meet other study criteria to take part in the study. Some medical conditions are excluded.
How to Apply
If you meet the above criteria, please click the link below to fill out a brief questionnaire to determine if you’re eligible to participate in a phase III COVID vaccine study. If you meet all eligibility requirements and are selected to participate, you will be matched to a study site near you and will be contacted to schedule your first appointment.
Frequently Asked Questions
This vaccine has been tested in more than one thousand people. Since we are still studying this vaccine, there may be risks that are unknown at this time. All known side effects from the vaccine will be reviewed with you in person during the Informed Consent process. If you decide to participate in the trial, the study team will work closely with you to monitor your health and will inform you if our understanding of the vaccine or potential side effects changes while you are in the study.
Yes, participants will be compensated for their time, at $100 per clinic visit. Compensation will be reviewed during the informed consent process.
You will be randomly assigned to receive two injections of either the vaccine or a placebo. You are two times more likely to receive the vaccine than the placebo. You will not know, and the study team will not know, whether you received the vaccine or the placebo until after you complete the study.
No. The vaccine is made from only a piece of protein from the virus. For any virus to replicate (grow) and cause disease it needs to be able to infect our cells and to grow inside those cells. This is not possible with this type of vaccine technology.
The study will not expose participants to the COVID-19 virus (SARS-CoV2). Volunteers may be exposed to COVID-19 in the community as part of their usual activities, so volunteers should continue all precautions to prevent COVID-19, just as they were before participating in the study.
There is currently no approved vaccine for COVID-19 (as of September 2020). This study will determine if this vaccine is sufficiently effective to prevent COVID-19. It will also add more information on how people feel after they receive the vaccine, and if they have any side effects (the safety profile). Once enough information has been compiled from this work, if it appears to work well to prevent COVID-19 illness and has minimal side effects, all of the information will be submitted in a licensure application to the Food and Drug Administration (FDA).
Yes, most individuals with underlying medical conditions are eligible to participate. However, your condition must be stable, meaning no worsening of your condition in the past few months. The study team will review eligibility requirements with you in detail during the screening process.
No. In order to participate in the study, you cannot have had a previous confirmed diagnosis of COVID-19.
Yes, you will need to visit the study center (located within Chittenden County) several times over the course of the study.
It is possible that the trial period may be shortened if the vaccine is deemed effective before you finish your two years in the study. After the trial has ended, participants will be informed whether they received the placebo or vaccine.
This study is being run through the Vaccine Testing Center at the Larner MD College of Medicine at the University of Vermont. Click here to learn more about the Vaccine Testing Center.
Contact the COVID-19 Vaccine Study Team:
COVIDStudyRecruitingUVMHealth [dot] org (Email Our Team)