Participation by people of all backgrounds is critical to developing a vaccine that may help prevent Lyme disease. The greater the representation among clinical trial participants, the more we can learn about the potential vaccine and how it works for different people.
Introducing a clinical trial for a Lyme disease vaccine that may offer protection against a common tick-borne illness.
Nearly 500,000 people in the US are diagnosed with Lyme disease every year.1 A vaccine to prevent Lyme disease could help protect people who visit or live in areas where ticks are common.
This clinical trial will help us learn if an investigational Lyme disease vaccine is safe and understand how different vaccination schedules affect the immune system’s response.
1 Kugeler KJ, Schwartz AM, Delorey MJ, et al. Estimating the frequency of Lyme disease diagnoses, United States, 2010–2018. Emerg Infect Dis. 2021;27(2):616-9.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering participation as an option that may be right for you.
This clinical trial may be an option if you:
- Are 18-44 years old
- Are generally healthy with no major changes in your recent medical history
- Do not have a history of severe allergic reactions associated with any vaccine
- Are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine
- Have never received a vaccine for Lyme disease
There are other requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more.
Age
18 to 44 years
Medical and vaccination history
Generally healthy, and have never received a vaccine for Lyme disease
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study is a good fit for you and you agree to take part, you will be assigned by chance (like pulling a number out of a hat) to 1 of 4 different vaccination schedules.
You will receive 5 injections (shots) over about 18 months. 4 of the shots will contain the study vaccine, and 1 will contain a placebo (injection with no active ingredients). You will not know or get to choose the order in which you receive your injections.
There is no cost to participate. You will also be paid for completing study-related activities and reimbursed for some study-related expenses.
Length of study
About 2 years
Number of study visits
At least 8 in-person visits and 3 phone calls
About Lyme disease
Lyme borreliosis, also known as Lyme disease, is caused by bacteria found in ticks. Bites from infected ticks can transfer the bacteria to humans and cause rashes, fever, and tiredness. Lyme disease can sometimes cause serious or long-lasting problems, even after treatment. Currently, the best way to prevent Lyme disease is to avoid tick bites.
Your participation matters
Your participation matters
Frequently asked questions
What are the possible benefits of participating in this clinical trial?
You will receive multiple doses of an investigational vaccine that may help to prevent Lyme disease at no cost. Additionally, your health will be closely monitored by the study team, and you will be contributing to research that will help us learn more about how to prevent Lyme disease in the future.
What are the potential risks of participating in this clinical trial?
The study vaccine may cause serious symptoms or side effects, including an allergic reaction. Study-related blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
What kinds of tests and procedures will be performed?
At the beginning of the clinical trial, the study doctor will ask you about your medical history including previous vaccinations and any medications you are currently taking. You will also have your blood drawn up to 4 times during the 2 years you are in the clinical trial. The study team will give you more information about the tests and procedures during the review of the Informed Consent Document (ICD).
Is there anything I am required to do outside of going to study visits?
You will need to use an electronic diary (eDiary) to report any changes in your health every evening for at least 7 days after receiving each study vaccination. The study team will provide more information about the eDiary during the review of the Informed Consent Document (ICD).
What if I change my mind?
Participation is your choice. You can choose to leave the clinical trial at any time for any reason, and your regular medical care will not be affected.
