Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

C4601003 - A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OSPA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE

This important study is looking into a new vaccine designed to protect people from Lyme disease, a condition caused by bacteria spread by tick bites. The vaccine, called VLA15, is being tested in people aged 5 and above. Researchers want to understand if the vaccine successfully stops people from getting Lyme disease. They are also carefully checking for any side effects, both mild ones like pain where the injection was given, and more serious ones. Another key part of the study is to see how the immune system (the body's natural defence) responds to the vaccine. Participants will be compared to others who receive a dummy injection (placebo) to fairly assess the vaccine's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

3,000

Start

01 Oct 2024

Active immunization against Lyme disease

What is this study about?

Imagine a shield that could help protect you from Lyme disease, a condition caught from tick bites that can cause various health problems. This study is all about testing a new vaccine, called VLA15, which aims to be that shield. The main goal is to find out if this vaccine can really stop people from getting Lyme disease and to make sure it's safe to use.

Researchers are giving the vaccine to healthy people aged 5 years and older, and then carefully watching to see if they get Lyme disease. They're also comparing this group to another group who receive a 'dummy' injection (called a placebo), which looks just like the vaccine but doesn't contain the active ingredients. This helps them understand if any effects they see are truly due to the vaccine or if they would have happened anyway.

By doing this study, scientists hope to gather enough information to show if the VLA15 vaccine is an effective and safe way to prevent Lyme disease. If successful, this could offer a new way to protect many people from this illness.

Key takeaways

This study is testing a new vaccine (VLA15) for Lyme disease.
It's open to healthy people aged 5 and over.
Researchers want to know if the vaccine prevents Lyme disease and if it's safe.
Some participants will receive the vaccine, others a dummy injection (placebo).
You'll have regular check-ups and blood tests if you take part.
Your participation could help develop a new way to prevent Lyme disease.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. There isn't an upper age limit, so adults of many ages might be able to take part. The study is open to both men and women.

It's important that participants are healthy before joining the study. This helps researchers focus on how the vaccine affects healthy individuals. Exact health requirements will be discussed in detail by the study team, as some medical conditions or medications might mean someone can't join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you generally in good health?
Are you able to attend appointments regularly at the study clinic?
Are you willing to potentially receive either the vaccine or a placebo?
Are you comfortable having blood samples taken during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new vaccine (VLA15) or a dummy injection (placebo). Neither you nor the study staff will know which one you receive. You'll need to attend several appointments at the clinic for injections and check-ups. During these visits, the study team will carefully monitor your health, ask about any symptoms or side effects you might have, and take blood samples to see how your body is reacting to the vaccine. There will also be a follow-up period to track your health over time. The study will last for a set period, which will be explained in full, probably over several months or even a few years.

Potential risks and benefits

Potential benefits of taking part include contributing to the development of a vaccine that could protect against Lyme disease, which might help future generations. You would also receive careful medical monitoring throughout the study. However, like all vaccines, VLA15 may cause side effects, such as pain or swelling where you had the injection, or general feelings of being unwell like fever or headache. There's also no guarantee that the vaccine will protect you from Lyme disease. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Netherlands
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Unverified
Poland
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Unverified
Finland
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Unverified
Germany

Common questions

What is Lyme disease?

Lyme disease is an infection caused by bacteria spread through the bite of infected ticks, which can cause symptoms like a rash, fever, and if untreated, more serious problems affecting joints, the heart, or nervous system.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real vaccine but doesn't contain any active ingredients. It's used to fairly compare the effects of the actual vaccine.

Will I know if I've received the vaccine or the placebo?

No, neither you nor the study staff will know whether you've received the vaccine or the placebo. This is to ensure the study results are fair and unbiased.

What are the main things researchers are looking for?

They mainly want to see if the vaccine prevents Lyme disease, if it's safe (looking for side effects), and how your body's immune system responds to it.

Who is sponsoring this study?

The information provided does not specify the sponsor, but clinical trials are typically sponsored by pharmaceutical companies or research organisations.