Lyme disease is a serious illness, and it’s more common than you think. If detected early, Lyme disease is often treated successfully. Earlier treatment leads to better outcomes. We are developing a new diagnostic test by using the natural power of the immune system to detect disease. If you have been recently diagnosed or suspect you may have Lyme disease, you might be able to help.
You’ll receive $50 for each study visit to compensate you for your time and participation
One blood draw for most participants – equivalent to 7 tablespoons. Some participants will have the option of contributing more in the future.
Why should I participate?
Building a better diagnostic will mean better results for the hundreds of thousands each year who contract Lyme disease.
Why that matters
Current Lyme disease tests only produce positive results for 30% of those with Lyme. Better tests mean earlier treatment which can make all the difference in outcomes of the disease.
Fill out the questionnaire to see if you qualify
If you qualify, a local study site will contact you to schedule a telehealth or in person visit – your choice.
Donate a blood sample and share relevant medical information with a study physician.
Why Participate in the ImmuneSense™ Lyme Study?
Millions of Americans have been affected by Lyme disease. The lack of accurate testing in the early stages of the disease makes it harder to get the right treatment at the right time, which is essential to managing the disease. By participating in the study you might help create a better test, which will help members of your community be treated earlier.
Why does this matter?
The immune system is nature’s most powerful diagnostic, and whenever it responds to a disease, it creates a signature. Adaptive has developed technology to read that signature and is using it to create new diagnostic tests.
About the Sponsor
The study is sponsored by Adaptive Biotechnologies, an immune-driven medicine company, in partnership with Microsoft, who are working together to decode the immune response to Lyme disease and other infectious diseases, autoimmune conditions, and cancers.
What is the purpose of this study?
Lyme disease is transmitted to humans via infected ticks. If left untreated, Lyme disease can become a serious illness for many people, but if caught early, Lyme disease can be typically be treated with antibiotics and long-term complications can be avoided. However, many people are misdiagnosed or undiagnosed because the disease is difficult to detect in its earliest stages when it is easiest to treat. The goal of this study is to see if we can diagnose Lyme disease earlier and better than currently available tests.
ImmuneSense™ Lyme is a study designed to better understand the immune response to Lyme disease. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot. De-identified data collected from this study may accelerate the development of better diagnostics for Lyme disease and improve outcomes for many.
The ImmuneSense Lyme Study is part of a partnership between Adaptive Biotechnologies with Microsoft to use artificial intelligence (AI) to accelerate our ability to map how the immune system responds to diseases. To learn more about this partnership, click here.
The process is an experimental process. “Experimental” means that the process is currently being tested and is not yet sure to work as it is supposed to work. Standard testing will be done as well to see how the results compare.
If I think I have Lyme disease can I participate in this study?
Yes, we are looking for participants who have the signs and symptoms of Lyme disease or were recently diagnosed and have not taken antibiotics for more than 3 days (see below for more formal criteria).
If I don’t have Lyme disease, can I participate in this study?
Yes, we are also looking for participants who either:
1. Are healthy and do not have the signs and symptoms of Lyme disease and have never had Lyme disease (see below for more formal criteria)
1. We are also looking for people with confirmed diagnoses for diseases that overlap with Lyme disease. These include:
2. Viral illness: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19
3. Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or ehrlichiosis
4. Bacterial infections: syphilis
5. Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE), Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), chronic fatigue syndrome
Is ImmuneSense™ Lyme enrolling participants near me?
96% of all Lyme cases are concentrated in 14 states in the Northeast, mid-Atlantic, and upper Midwest. ImmuneSense Lyme is operating in all the following areas: Maryland – Elkridge, Rockville; New York – Binghamton; Pennsylvania – Pittsburgh, Uniontown; Rhode Island – Warwick; Virginia – Burke, Danville. More sites coming soon in Connecticut, Maine, Massachusetts, Minnesota, New Hampshire, New Jersey, New York Pennsylvania, Wisconsin.
We are also looking for participants in areas that have a low number of reported cases of Lyme disease for participants that are healthy and have diseases that might overlap with Lyme disease in all of the following areas: Georgia – Macon; Louisiana – Baton Rouge; Nebraska – Omaha; Ohio – Cincinnati; Oklahoma – Yukon; South Dakota – Dakota Dunes. Additional sites across the country to open shortly.
If you are eligible to enroll and live near those locations, you may participate. If there isn’t a physical site nearby your location, you will be recommended for a virtual “telehealth” visit, but a visit to the study site is still required to submit a blood sample.”
If ImmuneSense Lyme is not in my area, can I go to a nearby area where it is operating?
Yes, you may travel to a site if you wish, and travel for a medical visit is exempt from stay-at-home guidelines.
If ImmuneSense Lyme is operating at a site outside of my insurance plan, can I still participate?
Yes, you will be eligible to participate. For this study, we will not be providing routine healthcare or treatment. This means that routine clinical care for Lyme disease should be followed by your in-network physician, but can be provided by an out-of-network doctor if needed. Please check with your insurance to determine any out-of-pocket costs for routine health care outside of the study. You and your insurance will not be billed for any study-related procedures.
This study will not alter or interfere with the normal care you receive in any way. You can see a doctor that is affiliated with this study without interfering with your normal care.
If you receive a diagnosis from your own provider, you can enroll in the study. You will have a study visit with the site doctor or a virtual telehealth visit to collect any study-related medical information and your relevant medical records will be accessed. You will not be charged, nor will your insurance be billed for the study visit. You will also provide your blood sample at no cost to you or your insurance.
How do I know if I am eligible? What should I ask my doctor?
Through the ImmuneSense Lyme Study, we are looking for participants who suspect they have Lyme disease or are recently diagnosed, but are within 3 days of starting their course of treatment for Lyme disease.
A confirmed diagnosis can be obtained through three routes, either:
– Through the ImmuneSense Lyme Study’s telemedicine option
– Through the ImmuneSense Lyme Study’s site healthcare provider(s)
– Through your own doctor .
If you have recently spent time outdoors, taking part in activities such as hiking, camping, gardening, dog-walking, or more, and present with some of the below symptoms, that might be cause to suspect Lyme disease and seek a diagnosis:
– Bulls-eye Rash
– Body aches
– Eye pain
– Chest tightness
– Joint pain
If you have questions about whether you may qualify, please reach out to the study team
What should I expect with participation in the ImmuneSense Lyme Study?
Your participation in this study is expected to last from 1 day if you are not in the Lyme disease group or up to 1 year, including a total of three follow up visits during that time frame if you are in the Lyme disease group. If you choose to take part in this study, you will review and sign the Adult & Parental Informed Consent Form. If you meet all the study requirements, you will be entered into the study.
Study Visit or Telehealth Visit
1. Study medical information
a. The study doctor will collect information about your medical history, symptoms, exposure history, and medical information related to Lyme disease that will help us better analyze and understand the data we collect about your immune system.
b. If you have a rash that is specific to Lyme disease, a photograph will be taken of that rash, and measures will be put in place to protect your privacy. All study information will be stored with a code in place of your name. All information recorded will be de-identified in accordance with HIPAA standards.
2. Blood draw
a. You will have the option to complete your blood draw(s) at the study doctor’s office. The blood draw will be approximately 6 tablespoons if you are an adult or between 1-2 tablespoons for a child.
Once you have completed all responses to the questionnaire and you have had the blood collection, you will be compensated $50 for your participation.
Follow-up Study Visits
If you have been diagnosed with Lyme disease or are suspected of having Lyme disease, you will be asked to participate in three additional study visits throughout a 12-month time period at 1 month, 6 months, and 12 months. Completion of each visit includes both a blood draw and discussing your symptoms and medical information relating to Lyme disease with a study doctor to collect study-related medical information.
You may withdraw your consent at any time. You can complete the ImmuneSense Lyme Study without participating in or consenting to additional blood draws and study visits or telehealth visits. Each additional blood draw will be approximately 6 tablespoons if you are an adult or between 1-2 tablespoons for a child.
You will receive additional compensation of $50 for each follow-up blood draw and study site or telehealth visit you complete, up to a total of three.
Are there risks and discomforts to me by participating in this study?
Potential physical risks associated with drawing blood, include: soreness at the site of puncture, bruising, and in rare cases, infection of the blood draw site, fainting, nerve or tendon damage.
Will I receive any results from the ImmuneSense Lyme Study?
The overall results of the study may be published; however, all protected health information (PHI) that could potentially identify you will be completely removed, and all data presented would be de-identified in accordance with HIPAA. Adaptive, as the Sponsor, will not return any additional individual results from this study nor provide results directly to participants.
Are there any direct benefits to me being in the ImmuneSense Lyme Study?
You will not receive any direct benefits from being in this study.
However, allowing the study team to analyze your samples may lead to a better scientific understanding of Lyme disease and improved diagnostics.
Are there any direct costs to me for my participation?
No, all study related procedures will be covered and your insurance will not be billed. This includes medical record review and collecting relevant medical information by a study doctor and a study-related blood draw. If you receive care outside of the study by a study doctor, this visit or procedures will be billed to your insurance.
For example, if you believe you have symptoms consistent with Lyme disease, and you would like to see a study doctor for routine care to treat and diagnose Lyme disease, this is outside of the scope of the study. Therefore, this visit will be billed to your insurance. If the study site is in your insurance network, then it will incur the same cost; if it is out-of- network, you may be responsible for the full cost of the visit. You will not incur cost for any aspects of the blood draw associated with this study or medical information review by the study doctor that is for this study.
Will I be compensated for my participation?
You will be given a $50 for your participation in the ImmuneSense Lyme Study. You must discuss any study-related medical information with the doctor (all questions answered) and complete a blood draw to qualify.
If you are diagnosed with Lyme disease or suspected of having Lyme disease, and you complete the longitudinal study visits (at 1 month, 6 months and 12 months), you will be compensated an additional $50 for each study visit and blood draw.
What does it mean to select to share my story in the consent form?
For those who mark that they are willing to share their story, Adaptive may contact you to discuss your experience with Lyme disease and your journey to a diagnosis. This is entirely optional and separate from any medical information that you share through your general participation with the study.
If you have questions on this, you can contact: ImmunseSenseLyme@adaptivebiotech.com
May I withdraw or revoke (cancel) my authorization for use and disclosure of my health information?
Yes, you may withdraw (revoke) your permission to use and disclose your health information at any time. You do this by sending written notice to the enrolling site or study doctor. However, if you withdraw your permission for use and disclosure of your health information, you will not be able to stay in this study. Also, although withdrawing your permission will prevent further uses and disclosures of your health information, it will not invalidate uses and disclosures that have already been made at the time the permission is withdrawn. This permission will be good until December 31, 2060.
Is my health information protected after it has been given to others?
Every effort will be made to ensure confidentiality of Protected Health Information (PHI) in accordance with HIPAA.
Is the confidentiality of my health information protected?
Total confidentiality cannot be guaranteed but disclosures of your health information will be very limited, as described above. And, as mentioned, to the extent the results of this research study are presented at meetings or in publications, your identity will never be included in the information that is disclosed. Government agencies or staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk.
Is my participation voluntary and can I withdraw at any time?
Your participation in this study is voluntary. You do not have to provide blood for this study and if you do provide samples and then later change your mind about your samples being stored and used, you can ask for any remaining samples to be destroyed. If you do change your mind, please notify your study staff in writing. If you withdraw your permission to use your samples, no new testing will be done; however, the results of any tests already performed will remain in the study data.
Your participation in this study may be stopped at any time by the study doctor or the Sponsor without your consent for any of the following reasons:
if it is in your best interest, you do not consent to continue in the study after being told of changes in the research that may affect you, or for any other reason.
Will I be informed if there are any changes to the study that affect me?
You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.
I have additional questions, who can I contact?
Please email the study staff at AdaptiveLymeStudy@iqvia.com
For any of the following reasons:
• if you have any questions about the ImmuneSense Lyme Study or your part in it
• if you feel you have had a research-related injury
• if you have questions, concerns, or complaints about the research.
If you have questions about your rights as a research participant or if you have questions, concerns, or complaints about the research, you may contact:
Western Institutional Review Board® (WIRB®)
1019 39th Avenue SE Suite 120
Puyallup, Washington 98374-2115
Telephone: 1-800-562-4789 or 360-252-2500
WIRB is a group of people who independently review research.
You may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.
WIRB # 20201525