COVID-19 vaccine clinical study in Minnesota

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.

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.

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 research@healthpartners.com.

We have many resources available to help you learn more about COVID-19 and continue to get the high quality care you need.