We’re proud to announce, with hope and renewed optimism, a big step forward in the fight against COVID-19. HealthPartners Institute has joined Oxford University and AstraZeneca in providing Minnesota’s first Phase 3 COVID-19 vaccine clinical trial.
You may be able to take part in the study if you:
- Are at least 18 years old
- Are in good or stable health, including having a well-managed underlying medical condition
- Have an increased risk of getting COVID-19, like working in a close-contact profession
- Don’t have a previously confirmed COVID-19 diagnosis
If you’re interested in participating, please start the screening process. If you’re eligible to participate and we’re able to schedule you for an appointment, we’ll contact you with more information.
A clinical trial is an important study that helps to answer important questions about an investigational vaccine or medicine, such as how well it works, how safe it is and whether there are side effects. All vaccines must be tested in clinical trials before they can be approved to give to patients.
This study is a Phase 3 trial, which occur toward the end of vaccine development after completing smaller Phase 1 and Phase 2 safety and effectiveness studies. The purpose of this Phase 3 trial is to learn more about an investigational vaccine for the prevention of COVID-19. COVID-19 is caused by the novel coronavirus.
If you are selected to participate, the clinical trial team will explain the possible benefits and risks to you. You can choose not to participate before the trial begins. You can also choose to stop participating at any point during the trial.
We’re proud to help advance this important research, and we’re excited to support study participants during this critical next research step.
If you’re selected to participate, you’ll receive more information about what to do and where to go.
People enrolled in the trial will participate in Bloomington, Minnesota. Once you have a scheduled appointment, you’ll get an email with the consent form, a document that explains what you need to know about the trial before you come in. You’ll be required to review the consent form before you arrive for your first study visit.
At your first study visit, you’ll go through an intake and consent process. We’ll confirm you meet the eligibility criteria, answer all your questions and confirm you agree to participate. Then, we’ll perform a brief physical exam and collect some blood for laboratory tests. Afterward, you’ll randomly receive either the vaccine or a placebo, which is sterile salt water.
The injection of vaccine or placebo will be given in your upper arm, like a flu shot. About two-thirds of people will receive the vaccine, while one-third will receive the placebo – who receives which is completely by chance, similar to flipping a coin. This is to make sure we can know if the vaccine works or not.
Over the next month, you’ll come in for one or two additional assessment visits (including one additional injection).
Over the next year, we’ll follow up with you every week to see how you’re doing and determine if you have any symptoms of COVID-19.
Over the next two years, you’ll come in for up to six more assessment visits, where we’ll collect some blood to see if the vaccine is working.
Participating in the trial is always voluntary – you can choose to stop taking part at any time. At the end of the trial, you’ll be able to see the results of the entire study.
If you develop signs or symptoms of COVID-19, you’ll come in to the clinic for a visit.
We’ll perform some testing, help you get the right care and ask you to keep track of your symptoms at home. We’ll also give you a monitor to check your temperature, breathing rate, heart rate and oxygen level. Depending on your test results or how your symptoms change, we may ask you to come in for additional visits.
A participant in a clinical study in the United Kingdom had an unexpected reaction to part of the vaccine used in our study (AZD1222). Enrollment was paused while an independent group of scientists looked into the incident to see if there was a safety risk for others.
This is the normal process in clinical trials and reflects how seriously the safety of the potential vaccine is monitored.
On September 12, the independent scientists completed their evaluation and recommended that studies were safe to resume in the U.K. United States regulators are looking at the evaluation and recommendation as well, and our study will resume once they approve.
You may receive up to $1,000 for your time and expense if you attend all scheduled assessments and visits. The study injections and study-related tests are also provided at no cost to you.
There were many different technical issues and inconsistencies with the scheduling website that was first used for appointments for this study.
Because of this, the HealthPartners Institute team has taken over the scheduling process. We’re using a new screening and scheduling process that we hope will improve reliability and the experience for interested participants. We’re sorry for any inconvenience.
We’ve had overwhelming interest in the study. Unfortunately, that means we’re not able to accommodate everyone who’s eligible and interested.
If we’re able to find room for you in the study, we’ll contact you with more information.
Interested in other clinical studies? You can always check open studies at HealthPartners Institute.
You may not be eligible for several reasons, including (but not limited to):
- You previously tested positive for the coronavirus.
- You have a serious health condition that required hospitalization in the past year.
- You’re pregnant.
- You’re not at increased risk of getting COVID-19.
We’re very thankful for your interest in wanting to advance health care research and make our community a safer, healthier place for everyone. If you’re interested in other clinical studies, you can always check open studies at HealthPartners Institute.
HealthPartners Institute improves care, health and well-being through research, education and practice. We’re part of HealthPartners, the largest consumer-governed, nonprofit health care organization in the nation.
Each year, we conduct hundreds of research studies to advance treatment, care and systems in order to improve lives and share findings across the world. We are active in many areas of research, and our research portfolio features a broad range of study topics, from cardiology and cancer to neurosciences and much more. We also support the clinical learning environment at HealthPartners by providing accreditation, resources and support for the training of many health professions.
Nationally known for our impact on health and well-being, we’re committed to making good happen in our community and beyond. Through taking part in a clinical trial, study participants can join us in contributing to the improvement of health and health care, both locally and nationally.
For questions about this COVID-19 vaccine Phase 3 trial, how clinical trials work, what clinical trials hope to find out and how clinical trials are organized, please visit HealthPartners Institute. You can also email HealthPartners Institute at firstname.lastname@example.org.
We have many resources available to help you learn more about COVID-19 and continue to get the high quality care you need.