RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)

This research is looking at a new vaccine, called mRNA-1982, designed to protect people from Lyme disease. The main goals are to check if it's safe to use, how your body reacts to it (like if you get a sore arm), and how well it helps your body build up protection against Lyme disease. The study includes healthy adults between 18 and 70 years old. Some participants will receive the new vaccine, while others will get a placebo (a dummy injection with no active medicine). This helps researchers understand the vaccine's real effects. This is a Phase 2 trial, meaning it's a further step in testing after initial safety checks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

ModernaTX, Inc.

Enrolment target

350

Start

29 Apr 2026

Estimated completion

09 Nov 2028

Lyme Disease

What is this study about?

You might have heard about Lyme disease, which is an illness you can get from a tick bite. It can cause problems like rashes, headaches, and tiredness, and sometimes more serious issues if not treated. Scientists are currently working on new ways to prevent it.

This particular study is focused on a new type of vaccine called mRNA-1982. This vaccine uses a special message, called mRNA, to teach your body to fight off the bacteria that cause Lyme disease. It's similar to how some of the recent COVID-19 vaccines work. The main idea is to see if this vaccine can safely prepare your body's immune system to recognise and fight off the Lyme disease bacteria before you ever get sick.

The researchers want to learn two main things: firstly, how safe the vaccine is and what side effects people might experience (like a sore arm or feeling a bit under the weather). Secondly, they want to find out how well the vaccine helps your body create protective substances, called antibodies, to guard against Lyme disease. By comparing results from people who get the vaccine with those who get a dummy injection (placebo), they can get a clearer picture of the vaccine's benefits.

Key takeaways

This study is testing a new mRNA vaccine (mRNA-1982) for Lyme disease.
It aims to check the vaccine's safety and how well it helps your body fight off Lyme disease.
Healthy adults aged 18-70 can apply to participate.
You might receive the vaccine or a dummy injection (placebo).
Participation involves regular clinic visits and health checks.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 70 years old. A doctor will check your overall health to make sure you are suitable. If you could become pregnant, you'll need to use reliable birth control methods during the study.

However, there are some reasons why you might not be able to take part. For example, if you've ever had a very serious allergic reaction to any mRNA vaccine or its ingredients, this study wouldn't be right for you. Also, if you currently have Lyme disease, or have had it treated in the last three months, or have a long-term illness linked to Lyme disease, you wouldn't be able to join.

If you've already had a Lyme disease vaccine before, or if you had a tick bite very recently (within four weeks before the study starts), you also wouldn't be eligible. The study team will go through all these details with you carefully to see if you can take part.

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 between 18 and 70 years old?
Do you feel generally healthy?
Have you *never* had a serious allergic reaction to an mRNA vaccine?
Have you *not* had Lyme disease in the last 3 months?
Have you *not* had a tick bite in the last 4 weeks?
Have you *never* had a Lyme disease vaccine before?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic over a period of time. You would receive either the new mRNA-1982 vaccine or a placebo (a dummy injection) – you wouldn't know which one you received. During your visits, doctors and nurses would check your health, ask about any side effects, and take blood samples to see how your body is responding to the vaccine or placebo. You would be closely monitored throughout the study to track your health and any reactions. The total duration of your involvement in the study would be explained to you in detail by the study team.

Potential risks and benefits

The potential benefit of taking part is contributing to scientific knowledge that could lead to a new way to prevent Lyme disease. If you receive the vaccine, your body might also develop protection against Lyme disease, though this is not guaranteed as it's still being tested. Potential risks include common vaccine side effects like a sore arm, fever, or headache, or less common allergic reactions. As with any medical study, there's always a small chance of unforeseen risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Colchester Research Group
Verified postcode
Truro, Canada· Recruiting
Bluewater Clinical Research Group Inc.
Verified postcode
Sarnia, Canada· Recruiting
Stouffville Medical Research Institute Inc.
Verified postcode
Stouffville, Canada· Recruiting
Dr. Anil K. Gupta Medicine Professional Corporation Inc.
Verified postcode
Toronto, Canada· Recruiting
Diex Recherche Inc. - Division Joliette
Verified postcode
Joliette, Canada· Recruiting
Diex Recherche Inc. - Division Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting
Diex Recherche Inc. - Division Victoriaville
Verified postcode
Victoriaville, Canada· Recruiting
Diex Recherche Inc. - Division Quebec
Verified postcode
Québec, Canada· Recruiting

Common questions

What is an mRNA vaccine?

An mRNA vaccine teaches your body's cells to make a small, harmless piece of a germ. This teaches your immune system to recognise and fight the actual germ if you get infected in the future.

What is a Phase 2 trial?

A Phase 2 trial is when a new treatment or vaccine is given to a larger group of people to see if it's safe and effective, and to find the right dose. It's a key step after initial safety checks.

Will I get Lyme disease from the vaccine?

No, you cannot get Lyme disease from this vaccine. It doesn't contain the actual bacteria that cause the disease, just the genetic instructions to help your body learn to fight it.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real vaccine but contains no active medicine. It helps researchers compare results accurately.

How long will I be in the study?

The exact duration would be explained by the study team, but clinical trials often involve several visits over many months to monitor your health.

How to find out more

Moderna WeCare Team

wecareclinicaltrials@modernatx.com 1-866-663-3762 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.