Ongoing Clinical Trials for Lyme Disease
Currently, there is 1 ongoing clinical trial for Lyme Disease, testing a vaccine designed to prevent this tick-borne infection. The trial is being conducted across multiple European countries and is open to healthy individuals aged 5 years and older living in areas where Lyme disease is common.
Clinical trial locations
- Finland
- Germany
- Netherlands
- Poland
- Sweden
Study on the Effectiveness and Safety of the VLA15 Vaccine for Preventing Lyme Disease in Healthy Individuals Aged 5 and Older
This clinical trial is testing a vaccine called VLA15, which is designed to protect against six different types of bacteria that cause Lyme disease. The vaccine is given as an injection into a muscle using a pre-filled syringe. The main goal of the study is to find out how well the vaccine prevents Lyme disease and how safe it is for people of different ages, including children and adults.
Who can participate:
- People who are 5 years old or older (in some locations, only those 18 or older can join)
- Those who live in areas where Lyme disease is common and have lifestyles that put them at higher risk, such as:
- People who work outdoors in areas with ticks, like landscaping or forestry workers
- Those who enjoy outdoor activities such as hiking, camping, or gardening
- People living near wooded areas or who have pets that often bring ticks home
- Generally healthy individuals or those with stable chronic medical conditions
- People willing to attend all study visits, follow the study plan, and be reachable by phone
- Ability to provide informed consent (or have a parent/guardian provide consent for children)
Who cannot participate:
- Anyone who has already received a vaccine for Lyme disease
- People outside the age range of 5 to 44 years old
- Certain vulnerable populations as determined by the study doctors
What happens during the study:
Participants will receive a series of VLA15 vaccine injections, including a primary series and a booster dose. The vaccine works by helping the body’s immune system recognize and fight off the bacteria that cause Lyme disease. After each vaccination, participants will be monitored for any reactions at the injection site, such as pain, redness, or swelling, as well as for general symptoms like fever, headache, fatigue, muscle pain, or joint pain.
Regular follow-up visits will be scheduled throughout the study to check on participants’ health and measure how well the vaccine is working. At the end of the study, a final assessment will evaluate the overall health of participants and their immune response to the vaccine.
About the vaccine:
VLA15 is an investigational vaccine that targets a protein called OspA found on the surface of the bacteria that cause Lyme disease. By stimulating the immune system to recognize this protein, the vaccine aims to prevent infection when someone is bitten by an infected tick. The study is examining whether the vaccine provides protection across different age groups, from children to adults.
Summary
This clinical trial represents an important step in developing a preventive vaccine for Lyme disease, a tick-borne illness that can cause serious health problems if left untreated. The study is being conducted across five European countries—Sweden, Netherlands, Poland, Germany, and Finland—all regions where Lyme disease is prevalent.
The trial is unique in that it includes both children and adults, starting from age 5, which could provide protection for a wide range of people living in or visiting tick-prone areas. The VLA15 vaccine targets six different strains of the bacteria responsible for the disease, offering potentially broader protection than previous approaches.
For people living in areas with high tick populations or those who spend significant time outdoors, this trial offers an opportunity to contribute to the development of a vaccine that could prevent the fever, fatigue, joint pain, and potentially serious complications associated with Lyme disease. The multi-country approach also helps ensure that the vaccine’s effectiveness can be evaluated across different populations and settings.