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Study on the Effectiveness and Safety of the VLA15 Vaccine for Preventing Lyme Disease in Healthy Individuals Aged 5 and Older

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a vaccine for Lyme disease, which is an illness caused by bacteria transmitted through tick bites. The vaccine being tested is called VLA15, and it is designed to protect against six different types of the bacteria that cause Lyme disease. The vaccine is given as an injection using a pre-filled syringe. In this study, some participants will receive the VLA15 vaccine, while others will receive a placebo, which is a substance with no active ingredients.

The purpose of the study is to evaluate how well the VLA15 vaccine works in preventing Lyme disease, as well as to assess its safety and how well it is tolerated by participants. The study will also look at the immune response generated by the vaccine, which is the body's way of defending itself against infections. Participants in the study will receive a series of injections over a period of time and will be monitored for any reactions or side effects. The study will include people aged 5 years and older who live in areas where Lyme disease is common.

Throughout the study, participants will have regular check-ups to monitor their health and any potential side effects from the vaccine. The study aims to ensure that the vaccine is safe and effective for people of different ages, including children and adults. By participating in this study, researchers hope to gather important information that could lead to a new way to prevent Lyme disease in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose, procedures, and potential risks and benefits.
If you are under 18, your parent or legal guardian will need to provide consent on your behalf.
Step 2
Initial assessment
You will undergo an initial health assessment to ensure you meet the study's eligibility criteria. This may include a review of your medical history and a physical examination.
The assessment will determine if you are healthy and if any preexisting conditions are stable enough for participation.
Step 3
Vaccination schedule
You will receive the study vaccine, VLA15, which is a suspension for injection in a pre-filled syringe. The vaccine is administered through an intramuscular injection, meaning it is injected into a muscle.
The vaccination schedule includes a primary series and a booster dose. The exact timing and number of doses will be explained to you during the study.
Step 4
Monitoring and follow-up
After each vaccination, you will be monitored for any immediate reactions. You will also be asked to report any local reactions, such as pain, redness, or swelling at the injection site, as well as any systemic events like fever, headache, fatigue, muscle pain, or joint pain.
Regular follow-up visits will be scheduled to assess your health and the vaccine's effectiveness in preventing Lyme disease.
Step 5
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate your overall health and the immune response to the vaccine.
You will be informed about the study's findings and any relevant information regarding your participation.

Who can join the trial?

7 criteria

Participants must be 5 years of age or older at the time of joining the study. In some places, only those who are 18 years or older can join.
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Participants should live in areas where Lyme disease is common and have lifestyles that increase their risk of getting Lyme disease. This includes people who:
- Work in areas with ticks, like landscaping or forestry.
- Enjoy outdoor activities such as hiking, camping, or gardening.
- Live near wooded areas or have pets that often bring ticks home.
- Participants or their parents/legal guardians must be willing and able to attend all study visits, follow the study plan, and be reachable by phone during the study.
- Participants should be in good health as determined by their medical history and the judgment of the study doctor. Those with stable chronic medical conditions may also join.
- Participants or their parents/legal guardians must be able to give informed consent, which means they understand the study and agree to take part. This includes understanding all the requirements and restrictions of the study.

Who cannot join the trial?

3 criteria

Participants cannot join if they have had an active immunization against Lyme disease. This means if you have already received a vaccine for Lyme disease, you cannot participate.
Participants must be within the age range of 5 to 44 years old.
Both males and females can participate, but certain vulnerable populations may not be eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland
Verified
Synexus Polska Sp. z o.o.
Poznan, Poland

Trial locations

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Investigated drugs

VLA15 is a vaccine being tested to see if it can prevent Lyme disease. Lyme disease is an illness you can get from tick bites, and it can cause symptoms like fever, headache, and fatigue. This vaccine is designed to protect against six different types of the bacteria that cause Lyme disease. The study is looking at how well the vaccine works, how safe it is, and how the body’s immune system responds to it. The goal is to see if the vaccine can stop people from getting Lyme disease after they have received the full series of shots, including a booster dose. The study also checks if the vaccine works equally well in children and adults.

Sodium Chloride Solution 0.9%

What is already known about the treatment

VLA15 – VLA15 is a vaccine administered through an injection to help protect against Lyme disease, a condition caused by bacteria transmitted through tick bites. Currently, VLA15 is being studied in clinical trials to assess its effectiveness and safety in preventing Lyme disease in people aged 5 and older. The vaccine works by stimulating the body's immune system to recognize and fight off the bacteria responsible for Lyme disease. It is classified as an active immunization agent, specifically targeting the outer surface protein A (OspA) of the bacteria.

Investigated diseases

Lyme disease – Lyme disease is an infectious disease caused by the bacterium Borrelia burgdorferi, transmitted to humans through the bite of infected black-legged ticks. The disease often begins with a characteristic skin rash called erythema migrans, which appears at the site of the tick bite. As the disease progresses, it can cause symptoms such as fever, headache, fatigue, and muscle and joint pain. If untreated, Lyme disease can spread to the joints, heart, and nervous system, leading to more severe symptoms. The progression of the disease can vary, with some individuals experiencing long-term effects. The immune response to the bacterium can be measured through specific immunological assays.